Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray

This study is to assess the Onset of Action and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home.

Start Date30 Oct 2023

Sponsor / Collaborator

Meda Pharma GmbH & Co. KG

CTR20213407

/ CompletedPhase 3

一项多中心、随机、双盲、双模拟、三臂、平行对照评估GSP301 NS与Patanase®NS和内舒拿®NS治疗中国成人和青少年季节性过敏性鼻炎（SAR）的有效性、安全性、耐受性及药代动力学的III期临床研究

[Translation] A multicenter, randomized, double-blind, double-dummy, three-arm, parallel controlled Phase III clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetics of GSP301 NS compared with Patanase® NS and Nasonex® NS in the treatment of seasonal allergic rhinitis (SAR) in Chinese adults and adolescents

主要目的：旨在通过14天的研究治疗，比较GSP 301 NS相对于Patanase®NS和内舒拿®NS的有效性。次要目的：（1）评估每项治疗的安全性和耐受性。（2）研究糠酸莫米松和盐酸奥洛他定的药代动力学（PK）。

[Translation]

Primary Objective: To compare the efficacy of GSP 301 NS relative to Patanase® NS and Nasonex® NS through 14 days of study treatment. Secondary Objectives: (1) To evaluate the safety and tolerability of each treatment. (2) To study the pharmacokinetics (PK) of mometasone furoate and olopatadine hydrochloride.

Start Date06 Apr 2022

Sponsor / Collaborator

Grand Pharmaceutical (China) Co., Ltd.

[+1]

NCT03463031

/ CompletedPhase 3

A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Start Date16 Mar 2018

Sponsor / Collaborator

Glenmark Specialty SA

100 Clinical Results associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

100 Translational Medicine associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

100 Patents (Medical) associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

Literatures (Medical) associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

04 Dec 2023·Otolaryngologia Polska

Intranasal combo: fixed-dose combination of mometasone furoate and olopatadine hydrochloride in therapeutic strategies for rhinosinusitis

Article

Author: Borowicz, Jacek ; Wojas, Oksana ; Krzych-Fałta, Edyta ; Samoliński, Krzysztof ; Walkiewicz, Artur ; Lipiec, Agnieszka ; Samoliński, Bolesław

A novel strategy for the treatment of allergic rhinitis results from the innovative combination of antihistamine and intranasal corticosteroid drugs. By combining two preparations with different mechanism of action, this novel approach facilitates quick and effective controls of all upper respiratory tract allergy symptoms. The article presents the results of a study of olopatadine hydrochloride and mometasone furoate fixed-dose combination (GSP301) administered intranasally from a spray formulation, with an attempt at positioning the treatment within the ARIA and EPOS guidelines.

01 Jun 2023·Expert review of clinical immunology

Intranasal corticosteroid and antihistamine combinations in the treatment of allergic rhinitis: the role of the novel formulation olopatadine/mometasone furoate.

Review

Author: Ridolo, Erminia ; Malvezzi, Luca ; Nicoletta, Francesca ; Heffler, Enrico ; Barone, Alessandro ; Paoletti, Giovanni ; Canonica, Giorgio Walter

INTRODUCTIONAllergic rhinitis (AR) is a common disease with an important impact on the quality of life and very high management costs. In many patients, the poor control of rhinitis symptoms often requires the use of different drugs, and polytherapy tends to reduce therapeutic adherence. According to the latest version of ARIA guidelines, the currently recommended drugs for the treatment of moderate-to-severe AR are second-generation antihistamines, intranasal corticosteroids, and their combination, even in a single nasal spray device. A single medication with a rapid onset of action, acting on breakthrough symptoms too, would be advantageous, also in terms of patient compliance.AREAS COVEREDGSP301 (olopatadine 600 µg - mometasone furoate 25 µg) is a novel intranasal formulation, combining the second-generation antihistamine olopatadine hydrochloride with mometasone furoate. Here, we review the evidence for GSP301, especially concerning the efficacy and safety profile of this intranasal combination in the treatment of AR.EXPERT OPINIONThe evidence provided in the current review clearly supports the use of GSP301 as a novel intranasal corticosteroid/antihistamine combination with a well-documented efficacy and safety profile in terms of rapid symptom relief and good tolerability.

01 May 2023·Annals of Pharmacotherapy

Intranasal Olopatadine-Mometasone in the Treatment of Seasonal Allergic Rhinitis

Review

Author: Lipari, Melissa ; Lim, Lauren ; Kale-Pradhan, Pramodini

Objective: To review the pharmacology, efficacy, and safety of intranasal olopatadine hydrochloride-mometasone furoate (OM) combination in the treatment of seasonal allergic rhinitis (SAR). Data sources: The PubMed database and ClinicalTrials.gov were searched using the following terms: mometasone + olopatadine, GSP301, mometasone furoate, and olopatadine hydrochloride. Study Selection and Data Extraction: Articles published in English between January 1987 and August 2022 related to pharmacology, safety, and clinical trials were assessed. Data Synthesis: In 2 phase II clinical trials, twice-daily (BID) and once-daily (QDay) intranasal OM demonstrated significant improvements in reflective total nasal symptom score (rTNSS) (BID P < 0.001 and QDay P < 0.001) and instantaneous total nasal symptom score (iTNSS) (BID P < 0.001 and P < 0.0001; QDay P < 0.001 and P < 0.0001). In 2 phase III clinical trials, BID OM showed significant improvements in rTNSS vs. placebo ( P < 0.001), olopatadine monotherapy ( P = 0.03 and P = 0.003), and mometasone monotherapy ( P = 0.02 and P = 0.059). Relevance to Patient Care and Clinical Practice: OM is indicated for treatment of SAR symptoms. Caution with use must be considered for certain high-risk patients, existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Due to its quick and sustained onset of action, OM may be an ideal agent for initial treatment of moderate-severe SAR for patients 12 years and older. Conclusion: OM significantly improves SAR symptoms and is a viable treatment option in short-term SAR.

News (Medical) associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

10 Oct 2023

·synapse.patsnap.com

Inventory of GPCR Targeted Drugs Applying for Listing (I)

This article will review currently applied listed GPCR-targeting drugs, and the associated popular GPCR class targets and drug development opportunities worth paying attention to. 1.Eli Lilly: TirzepatideTarget:GIPR + GLP-1R Tirzepatide is a novel GIPR and GLP-1R dual agonist developed by Eli Lilly. In preclinical and clinical trials, compared to selective GLP-1 receptor agonists, GIP/GLP-1 dual agonists have been shown to better control blood sugar and reduce weight. Therefore, it is receiving increasing attention as a new therapeutic drug for controlling blood sugar and weight. In 2022, Tirzepatide was approved for the first time in the United States for the treatment of adult type II diabetes as an adjunct to diet and exercise. Subsequently, Tirzepatide was approved in the European Union and Japan for the treatment of type II diabetes. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. 2.ChemoCentryx: AvacopanTarget:C5aR Avacopan(Tavneos) is an orally administered, first-in-class selective complement 5a receptor (C5aR) antagonist, discovered and developed by ChemoCentryx. This drug is used as an adjunctive therapy for ANCA-associated vasculitis in adult patients. Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a rare ("oligo-immune") systemic small-vessel vasculitis, with an estimated incidence of 3 per 100,000 annually, characterized by the presence of ANCAs in the serum. The entire course of AAV includes granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), and drug-induced AAV. Despite its complex pathophysiology, research over the past approx. 20 years has determined the crucial role of the alternative complement pathway, particularly the interaction of C5a with the C5aR receptor in AAV. Avacopan was first approved for marketing in Japan on September 27, 2021, and was subsequently approved in the United States, European Union, Canada, and Australia for the treatment of adult patients with ANCA-associated vasculitis, granulomatosis with polyangiitis, and microscopic polyangiitis. In addition, research is ongoing for other potential clinical indications, such as hidradenitis suppurativa and C3 glomerulopathy. 3.Pfizer: Rimegepant Sulfate Target:CGRP Receptor Rimegepant is an orally administered CGRP receptor antagonist used for the acute treatment of migraine in adults, with or without aura. Initially developed by the BMS(BMS-742413), the newly established biotech company Biohaven Pharmaceutical acquired the exclusive global development and commercialization rights to Rimegepant in 2016. The Biohaven team conducted a series of clinical studies and analyses around Rimegepant and developed the derivative migraine nasal spray drug, Zavegepant. In May 2022, Pfizer announced that it would acquire Biohaven for a total cash consideration of approximately 11.6 billion USD. Rimegepant was first approved for marketing in the United States on February 27, 2020, and subsequently received approval in Israel, the United Arab Emirates, Kuwait, the European Union, and Iceland, among others. Currently, the drug is being tested in clinical trials for conditions like chronic sinusitis, nasal polyps, and trigeminal neuralgia. 4. Glenmark:RYALTRISTarget:H1R+GR RYALTRIS is a new compound prescription nasal spray developed by the Indian pharmaceutical company, Glenmark. This medication has the dual efficacy of activating glucocorticoid receptor (GR) and antagonizing histamine H1 receptor (H1R). Mometasone is a moderately potent synthetic corticosteroid that acts as a glucocorticoid receptor agonist, possessing anti-inflammatory, anti-itch, and vasoconstrictive properties. Olopatadine, on the other hand, is an antagonist of histamine H1 receptors used for the treatment of allergic conjunctivitis and rhinitis. Since histamine is the primary inflammatory mediator causing inflammation and allergic reactions, Olopatadine works by blocking the action of histamine receptors. Compared to other anti-allergic ophthalmic drugs, Olopatadine does not interfere with the cell membrane, thus offering good comfort and tolerability. RYALTRIS was first approved for marketing in Australia in 2019, and subsequently received approval for listing in South Africa, the UK, the US, Canada, and other countries. In 2019, Grand Pharmaceutical and Glenmark signed an exclusive licensing agreement, in which Glenmark granted Grand Pharmaceutical the exclusive rights to sell RYALTRIS in China. Glenmark would be responsible for the manufacture and supply of the authorized product, while Grand Pharmaceutical would be in charge of the clinical trials and registration work for the authorized product in China and can exclusively sell the approved product in China for 20 years upon approval. 5. Amgen:ErenumabTarget:CGRP Erenumab is a human monoclonal antibody developed by Amgen and is the first monoclonal antibody drug targeting GPCR approved by the FDA. Erenumab can specifically bind to and antagonize the Calcitonin Gene-Related Peptide Receptor (CGRPR), thus preventing migraines. In April 2017, Amgen announced an expanded commercial collaboration with Novartis on Erenumab, which is being studied for the prevention of migraine. This expanded business cooperation is based on the global neuroscience collaboration established by Novartis and Amgen in 2015 in the areas of Alzheimer's disease and migraine. Novartis initiated two clinical trials in China in 2019 to evaluate the safety and efficacy of Erenumab injection in the treatment of migraines. Erenumab was first approved for marketing in the United States in 2018, and was subsequently approved in Australia, Iceland, Norway, Switzerland, Canada, and Japan. In addition to the treatment of migraines, clinical trial research is ongoing for other indications, including headaches, hot flashes, temporomandibular joint dysfunction syndrome, stable angina. 6. Kyowa Kirin:EvocalcetTarget:CaSR Evocalcet is a Calcium-Sensing Receptor (CaSR) agonist developed by Kyowa Kirin, used for the treatment of hypercalcemia, secondary hyperparathyroidism, and other related conditions. Kyowa Kirin has applied for two clinical trials in China to evaluate the effectiveness of Evocalcet in treating secondary hyperparathyroidism in patients undergoing maintenance dialysis for chronic kidney disease. As of now, Evocalcet has only been approved for marketing in Japan. 7. Otsuka Pharmaceutical: BrexpiprazoleTarget:5-HT1A+5-HT2A+D2R Brexpiprazole is a serotonin-dopamine activity modulator developed by Otsuka Pharmaceutical, used as an adjunctive treatment for severe depression, schizophrenia, and agitation associated with dementia caused by Alzheimer's disease. Brexpiprazole is an atypical antipsychotic and a novel D2 dopamine and serotonin 1A partial agonist, known as a serotonin-dopamine activity modulator. It has a high affinity for serotonin, dopamine, and alpha-adrenergic receptors. Structurally, Brexpiprazole is very similar to another atypical antipsychotic drug, Aripiprazole, but Brexpiprazole has a different affinity for binding with dopamine and serotonin receptors. Compared to Aripiprazole, Brexpiprazole is less likely to produce adverse reactions mediated by partial agonist, such as extrapyramidal symptoms, due to its lower intrinsic activity at the D2 receptor. Brexpiprazole was first approved in the United States in 2015, and subsequently approved in Canada, Japan, and the European Union. In addition to treating depression, this drug is undergoing global clinical trials and research for multiple indications including agitation, schizophrenia, Alzheimer's disease, and performance anxiety. 8. Santen: TapcomTarget:PTGFR+βAR Tapcom is a combination eye drop medication containing Tafluprost and Timolol Maleate, developed by Santen. Tafluprost is a prostaglandin analogue used in ophthalmology to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Chemically, Tafluprost is a fluorinated analogue of prostaglandin F2-α. Timolol is a non-selective beta-adrenergic antagonist, used for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Tapcom was first approved for marketing in Japan in 2013, and subsequently received approval in countries including Iceland, France, Poland, and Germany. 9. Takeda:TeduglutideTarget:GLP-2R Teduglutide is a glucagon-like peptide-2 (GLP-2) analog developed by the British rare disease pharmaceutical giant, Shire Development, for the treatment of patients with short bowel syndrome (SBS) who require parenteral nutrition support. Teduglutide is comprised of 33 amino acids, and is manufactured using strains of E. coli that have been modified through DNA recombinant technology. Teduglutide differs from GLP-2 by one amino acid (alanine is replaced with glycine). This substitution results in Teduglutide having a longer duration of action than endogenous GLP-2 and a higher resistance to hydrolysis by the enzyme dipeptidyl peptidase-4. Teduglutide first received regulatory approval within the European Union in 2012, followed by approval in the United States and Japan, in all cases for the treatment of SBS. In 2019, Takeda Pharmaceuticals spent an astounding £46 billion to acquire Shire Development, in a move that has been dubbed as a "snake swallowing an elephant" merger in the pharmaceutical world. This acquisition propelled Takeda Pharmaceuticals into the list of top 10 global biopharmaceutical companies. Clinical research on the application of Teduglutide for the treatment of Crohn's Disease and kidney disorders was discontinued due to this acquisition. 10. AstraZeneca: Duaklir GenuairTarget:M3R+β2AR Duaklir Genuair is a combined Aclidinium Bromide/Formoterol Fumarate inhalation powder developed by AstraZeneca. This medication is used as a maintenance bronchodilator to alleviate the symptoms of disease in adults with chronic obstructive pulmonary disease (COPD). Among them, Aclidinium bromide is a novel long-acting muscarinic antagonist, and Formoterol fumarate is a long-acting β2 receptor agonist. Duaklir Genuair is administered by the Genuair dry powder inhaler twice a day and is the first combined medication that has shown a statistically significant improvement over monotherapy in terms of shortness of breath. Duaklir Genuair was first approved in the European Union in 2012, and subsequently in the United States in 2019, for the treatment of chronic obstructive pulmonary disease.

03 May 2023

·www.biospace.com

RYALTRIS, a new combination prescription nasal spray for moderate to severe seasonal allergic rhinitis (SAR), now available across Canada

New treatment from Bausch Health, Canada indicated to treat seasonal allergy and associated ocular symptoms in adults, adolescents and children 6 years and older LAVAL, QC, May 3, 2023 /CNW/ - Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) is pleased to announce the availability across Canada of its new prescription treatment RYALTRIS® (olopatadine hydrochloride and mometasone furoate nasal spray). RYALTRIS has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.1 "Bausch Health is very pleased that we are now able to make RYALTRIS available to Canadians, providing an innovative new combination nasal spray treatment for SAR, which impacts the lives of the over 9 million Canadians who suffer from SAR or seasonal allergies often referred to as hay fever,2" said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "The launch of this new therapy adds to our broad portfolio of treatments that further establishes Bausch Health as a trusted partner in the healthcare of Canadians." "Allergic rhinitis is a common disorder that often doesn't respond adequately to usual treatments" said Dr. Paul Keith, Professor, Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University. "Nasal congestion, nasal itch, runny nose and sneezing are classic symptoms of the disorder. Having a treatment, like RYALTRIS, that provides both a quick onset of symptomatic relief as well as an anti- inflammatory effect for moderate to severe seasonal allergic rhinitis and the associated ocular symptoms can really improve health outcomes and quality of life in adults, adolescents, and children aged 6 years and older." RYALTRIS is a fixed-dose combination therapy that combines two best-in-class anti-allergy products – the corticosteroid mometasone and the antihistamine olopatadine3 – to give rapid and sustained relief from the symptoms of SAR, both nasal and ocular, in one easy-to-use nasal spray at a competitive price. The onset of action for nasal symptom relief occurs within 15 minutes after administration of RYALTRIS.1 About RYALTRIS® The efficacy and safety of RYALTRIS® were established in a clinical studies program conducted by Glenmark Pharmaceuticals Ltd., its developers, in over 4300 healthy and allergic rhinitis patients with SAR. Twice-daily RYALTRIS provided statistically significant improvement in both nasal and ocular symptoms vs. placebo, as well as statistically significant onset of action in nasal symptom relief vs. placebo at 15 minutes, across three randomized, double-blind phase 3 studies (P<0.05). The safety pro RYALTRIS is typical of that observed with intranasal drugs of the same classes.1 Important Safety Information for Ryaltris® RYALTRIS® is an intra-nasal spray and should not be administered orally, instilled in the eyes, ears or applied to the skin. In 14-day clinical studies of patients with SAR taking RYALTRIS twice a day, the most common adverse events observed were altered taste (3%), nose bleeds (1%) and nasal discomfort (1%). RYALTRIS should not be used by anyone who has had an allergic reaction to olopatadine or mometasone or to any ingredient in the formulation or have untreated fungal, bacterial, or tuberculosis infections of the respiratory tract. Close medical supervision is required in anyone who has a weakened immune system, including those who have had infections with opportunistic pathogens. Increased risk of occurrence or potential worsening of pre-existing infections (e.g., tuberculosis) with fungi, bacteria or viruses can occur, including fatal chickenpox, measles and herpes infections in susceptible patients. RYALTRIS should be used under close medical supervision in anyone who has had nose bleeds or nasal perforation. Recurrence, worsening or persistence of these nasal problems can occur. The effect of RYALTRIS on pregnancy and through transmission in breast milk is not known. Talk to your doctor if you are pregnant, plan to become pregnant or breastfeeding, to ensure it is safe for you to use.1 About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Bausch Health, Canada Inc.'s prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada, in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at . About Glenmark Pharmaceuticals Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is an innovation–driven, global pharmaceutical company with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 world–class manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2021; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2021. The company has been Great Place To Work® Certified™ in India, in 2023. Glenmark has impacted over 2.6 million lives over the last decade through its CSR interventions. For more information, visit . Follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma). REFERENCES RYALTRIS® is a registered trademark of Glenmark Specialty S.A., used under license. SOURCE Bausch Health Company Codes: NYSE:BHC, Toronto:BHC

Clinical ResultPhase 3Drug Approval

30 Aug 2022

·www.prnewswire.com

Hikma launches RYALTRIS™ seasonal allergic rhinitis nasal spray in the US

RYALTRIS™ is the only fixed-dose combination therapy that provides relief for both nasal and ocular symptoms of seasonal allergic rhinitis in one easy-to-use nasal spray 60 million Americans suffer from allergic rhinitis and allergic conjunctivitis yet approximately 8.5 million are still impacted by poor nasal symptom control LONDON and MAHWAH, N.J.and MUMBAI, India, Aug. 30, 2022 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma, Group), the multinational pharmaceutical company, and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), an innovation driven global pharmaceutical company, announced the launch of RYALTRIS™ (olopatadine hydrochloride and mometasone furoate nasal spray) in the US. RYALTRIS™ is approved by the US Food and Drug Administration (FDA) for the treatment of symptoms of seasonal allergic rhinitis (SAR) in adult and pediatric patients 12 years of age and older. This launch builds upon Hikma's leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US. RYALTRIS™ is the only fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular in one easy-to-use nasal spray. The onset of action for nasal symptom relief occurs within 15 minutes of a patient taking the first dose.1,2,3 "Allergic rhinitis and allergic conjunctivitis are among the most common chronic diseases in the US today, affecting 60 million Americans each year,4 yet approximately one in seven US adults have reported their nasal allergy symptoms are either poorly controlled or not controlled at all,5 and ocular symptoms are reported to be as severe as nasal symptoms,"6 said Leonard Bielory, M.D. Professor of Medicine, Allergy, Immunology and Ophthalmology at Hackensack Meridian School of Medicine. "By combining two of the most frequently prescribed medicines used to address both the nasal and ocular symptoms of seasonal allergic rhinitis into one, easy-to-use nasal spray, RYALTRIS™ provides an important new treatment option for patients suffering from this chronic condition affecting the nose and eyes." Uncontrolled seasonal allergic rhinitis is a serious condition that places a substantial burden on patients and society as whole. The symptoms of allergic rhinitis can lead to chronic complications including asthma, sinusitis, hearing impairment, and other allergy-related complications7,8,9,10 which can have a significant impact on patients' quality of life.11,12,13 There is an important need for new treatment options like RYALTRIS™ to help treat seasonal allergic rhinitis, as patients who do not experience adequate symptom relief may require therapy escalation to more costly and higher-risk treatments such as immunotherapy, biologics, and surgery.14,15,16,17,18 "The launch of RYALTRIS™ is a significant step forward for Hikma in expanding our US nasal spray leadership into branded medicines and advancing our objective of growing our specialty business in the US," said Brian Hoffmann, President of Hikma Generics. "Importantly, it will allow us to leverage our strong, existing specialty salesforce already calling on doctors within our specialty portfolio. We look forward to bringing this important new treatment option to the millions of US patients suffering from seasonal allergic rhinitis." "We are delighted to partner with Hikma for the launch of our novel drug RYALTRIS™ in the United States, making it our first global branded specialty product to be marketed in the country. RYALTRIS™ is a result of our consistent efforts to offer high-quality medicines that benefit patients around the world. Available in major markets across the globe, this launch is a major milestone for Glenmark and demonstrates our focus in strengthening our global respiratory leadership," said Brendan O'Grady, Chief Executive Officer - Global Formulations Business, Glenmark Pharmaceuticals Ltd. About RYALTRIS™ The efficacy and safety of RYALTRIS™ was established in a robust clinical studies program in over 4,000 patients with SAR. Twice-daily RYALTRIS™ provided statistically significant improvement in both nasal and ocular symptoms vs. placebo,1,2,3 as well as statistically significant onset of action in nasal symptom relief vs. placebo at 10-15 minutes,1,2,3 across three randomized, double-blind phase 3 studies (P<0.05). RYALTRIS™ also provided significant and clinically meaningful sustained improvements in nasal symptoms versus placebo over 52 weeks with no evidence of tachyphylaxis in patients with perennial allergic rhinitis (PAR).1,2,3 RYALTRIS™ demonstrated a safety profile consistent with placebo, monotherapy, and comparator fixed-dose-combination treatment.1,2,3 About Seasonal Allergic Rhinitis Allergic rhinitis is one of the most common chronic diseases in the United States, affecting 60 million Americans annually.4 Season allergic rhinitis (SAR) occurs in a specific pollen season, and is an allergic reaction to pollen from trees, grasses, and weeds. According to the most recent CDC data, almost 20 million adults in the United Sates are affected by seasonal allergic rhinitis every year.14 It is estimated to affect more than seven percent of adults aged 18 years and over in the US.13 Enquiries Hikma Pharmaceuticals PLC Glenmark Pharmaceuticals Ltd. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,700 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB-/stable S&P and Ba1/stable Moody's) About Glenmark Pharmaceuticals Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 worldclass manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark is ranked among the world's top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical Sales, 2020, by In Vivo/Scrip 100) and among the world's top 50 companies in the off-patent sector (Top 50 Generics and Biosimilars Companies ranked by Sales, 2020, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year. For more information, visit . Follow us on Social Media: LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma) U.S. Important Safety Information for Ryaltris™ Ryaltris™ is an intra-nasal spray and should not be administered orally, instilled in the eyes, ears or applied to the skin. In clinical studies, the most common adverse events that were observed in those 12 years of age and over using Ryaltris™, were altered taste (3%), nose bleeds (1%) and nasal discomfort (1%). Ryaltris™ should not be used by anyone who has had an allergic reaction to olopatadine or mometasone. Close medical supervision is required in anyone who has a weakened immune system, including those who have had infections with opportunistic pathogens. Increased risk of occurrence or potential worsening of pre-existing infections (e.g. tuberculosis) with fungi, bacteria or viruses can occur; including fatal chickenpox, measles and herpes infections in susceptible patients. Ryaltris™ should be used under close medical supervision in anyone who has had nose bleeds or nasal perforation. Recurrence, worsening or persistence of these nasal problems can occur. Close growth monitoring of pediatric patients (12 years and over) by a medical practitioner is recommended with the use of Ryaltris™. Ryaltris™ effect on pregnancy and through transmission in breast milk is not known. Talk to your doctor if you are pregnant, plan to become pregnant or breastfeeding, to ensure it is safe for you to use. For more information, please see the full Prescribing Information and Patient Information 1 Patel P, et. al. Ann Allergy Asthma Immunol. 2019;122(2):160-166 2 Gross GN, et. al. Ann Allergy Asthma Immunol. 2019;122(6):630-638 3 Hampel FC, et. al. Allergy Asthma Proc. 2019;40(4):261-272 4 Meltzer EO. Immunol Allergy Clin North Am. 2016;36(2):235-248 5 Meltzer E, et al. Allergy Asthma Proc. 2012;33 (suppl 1):113-141. 6 Bielory L, et al. Allergy Asthma Proc. 2014 ;35(3):211-8. 7 National Institute for Health and Care Excellence. Complications allergic rhinitis. Updated April 29, 2019. Accessed January 2020. 8 Settipane RA. Allergy Asthma Proc. 1999;20(4):209-213. 9 Skoner, DP. J Allergy Clin Immunol. 2000;105(6 Pt 2) :S605-S609. 10 Chirakalwasan N, et al. Asian Pac J Allergy Immunol. 2014;32(4):276-286. 11 D'Alonzo, GE Jr. J Am Osteopath Assoc. 2002;102(6 suppl 2):S2-S6. 12 Marple et al. Otolaryngol Head Neck Surg. 2007;136(suppl 6):S107-S124. 13 Meltzer EO, et al. Allergy Asthma Proc. 2012;33(suppl 1):S113-S141. 14 Seidman MD, et al. Otolaryngol Head Neck Surg. 2015;152(1S):S1-S43. 15 Bhattacharyya N, et al. The Laryngoscope. 2019;129:1969–1975. 16 ICER 2018 Final Report of Biologic Therapies for Treatment of Asthma Associated with Type 2 Inflammation. *2018 Wholesale Acquisition Costs x 1 year of dosing for allergic asthma (on-label indication). Use of biologics for SAR is off-label & dosing strategies are not established. 17 Gevaert P, et al. J Allergy Clin Immunol. 2013;131:110-6. 18 Wu A, et al. J Allergy Clin Immunol Pract. 2021;9:1107-17. SOURCE Hikma Pharmaceuticals USA Inc.

Generic DrugBiosimilarImmunotherapyAcquisition

100 Deals associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	United States	Glenmark Specialty SA	13 Jan 2022
Rhinitis, Allergic	Australia	Seqirus Pty Ltd.	11 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	NDA/BLA	China	Grand Pharmaceutical (China) Co., Ltd.	30 Jan 2022
Rhinoconjunctivitis	Phase 3	China	Grand Pharmaceutical (China) Co., Ltd.	06 Apr 2022
Rhinoconjunctivitis	Phase 3	China	Glenmark Pharmaceuticals Ltd.	06 Apr 2022
Seasonal rhinitis	Discovery	United States	Glenmark Specialty SA	16 Mar 2018
Rhinitis perennial	Discovery	United States	Glenmark Specialty SA	01 Apr 2016
Rhinitis, Allergic, Perennial	Discovery	United States	Glenmark Specialty SA	01 Apr 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03463031 (Pubmed \| Ann Allergy Asthma Immunol) Manual	Phase 3	Rhinitis, Allergic, Seasonal	446	GSP301	hfxagqnzsz(zhuooschwl): difference = -0.6 (95% CI, -0.9 to -0.2), P-Value = 0.001 View more	Positive	01 Aug 2022
				Placebo
NCT03463031 (GSP 301-305, CTgov)	Phase 3	Rhinitis, Allergic, Seasonal \| Seasonal rhinitis	446	GSP 301 NS	sotvyagetu(awlcjvlagq) = atrdzeuxsx nrcsmzixmc (bsekwnmpwi, bpxxurycla - iolotehodu) View more	-	08 Oct 2019
NCT02709538 (GSP 301-303 \| GSP301, CTgov)	Phase 3	Rhinitis, Allergic, Perennial \| Rhinitis perennial	601	GSP 301 NS (GSP 301 NS)	aljvugdgim(irwizqdxsk) = rcgfqlabfw nbwiovsaqv (cibuavdvld, gcptmembuk - dmgfmchmaz) View more	-	13 Sep 2018
				GSP 301 Placebo NS pH 3.7 (GSP 301 Placebo NS pH 3.7)	aljvugdgim(irwizqdxsk) = ooqtwelgfc nbwiovsaqv (cibuavdvld, abvxhmaogp - muhhvpycac) View more
NCT02631551 (GSP 301-301, CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	1,180	GSP 301 NS (GSP 301 NS)	tnedjfponl(pqflprzwvb) = wyafcxbxda oxjcujxbft (vwfxualkmv, tzbdbnouqz - akpcborzau) View more	-	15 Aug 2018
				Olopatadine HCl NS (Olopatadine HCl NS)	tnedjfponl(pqflprzwvb) = ulfbdoxnbg oxjcujxbft (vwfxualkmv, tectlirgti - mhmwledojj) View more
NCT02870205 (GSP 301-304, CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	1,176	GSP 301 placebo NS (GSP 301 Placebo NS)	vmjcacqsiz(djdmouinrc) = fylqsxcfnb kqmakpejmj (xuyhfwxunm, bywsdrcvbo - ehdubfgyev) View more	-	06 Apr 2018
				GSP 301 NS (GSP 301 NS)	vmjcacqsiz(djdmouinrc) = okrqbrppif kqmakpejmj (xuyhfwxunm, kdrscaiiiy - vdhnbezobb) View more
NCT02318303 (CTgov)	Phase 2	Rhinitis, Allergic, Seasonal	1,111	GSP 301-1 NS (QD) (GSP 301-1 NS (QD))	awqwymvpkw(kyxksodsls) = tcclnyakxc eydcxlsfpc (skhpreeucf, uosvymrijo - lmjbznbqjz) View more	-	28 Jun 2017
				Mometasone Furoate-1 NS (QD) (Mometasone Furoate-1 NS (QD))	awqwymvpkw(kyxksodsls) = jbykerabfw eydcxlsfpc (skhpreeucf, dbszezuqsq - weyeovcudc) View more
NCT01118312 (STAN, CTgov)	Phase 4	Asthma \| Sinusitis \| Rhinitis	388	Mometasone Furoate monohydrate (Nasal Steroid)	elosidpnkv(ymreslykjq) = tdxbdhotsl sgfyediwee (eclzfihdlk, rebrqhvlwp - bhjhsbgzus) View more	-	30 Nov 2015
				Placebo (Placebo)	elosidpnkv(ymreslykjq) = vrhnfjmyei sgfyediwee (eclzfihdlk, aweopazoyw - yoarkywcvf) View more

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