[Translation] A randomized, open-label, two-dose, four-period, completely repeated crossover bioequivalence study of theophylline sustained-release tablets in healthy subjects under fasting and fed conditions

主要研究目的：本研究考察健康受试者在空腹及餐后条件下，单次口服由湖南绅泰春制药股份有限公司提供的茶碱缓释片（受试制剂，规格：100mg）与相同条件下单次口服由日医工株式会社持证的茶碱缓释片（参比制剂R，商品名：UNICONTM，规格：100mg）的药动学特征，评价两制剂间的生物等效性，为受试制剂的一致性评价提供依据。次要研究目的：观察健康受试者在空腹及餐后条件下单次口服100mg的受试制剂茶碱缓释片（规格：100mg）与参比制剂茶碱缓释片（商品名：UNICONTM，规格：100mg）的安全性

[Translation]

Main research purpose: This study investigates the pharmacokinetic characteristics of theophylline sustained-release tablets (test preparation, specification: 100 mg) provided by Hunan Shentaichun Pharmaceutical Co., Ltd. and theophylline sustained-release tablets (reference preparation R, trade name: UNICONTM, specification: 100 mg) certified by Nichiyo Co., Ltd. under the same conditions when taken orally once in a single dose in healthy subjects under fasting and postprandial conditions, evaluates the bioequivalence between the two preparations, and provides a basis for the consistency evaluation of the test preparation. Secondary research purpose: Observe the safety of the test preparation theophylline sustained-release tablets (specification: 100 mg) and the reference preparation theophylline sustained-release tablets (trade name: UNICONTM, specification: 100 mg) taken orally once in a single dose in healthy subjects under fasting and postprandial conditions

Start Date24 Nov 2023

Sponsor / Collaborator

Hunan Shentaichun Pharmaceutical Co., Ltd.

100 Clinical Results associated with Theophylline

100 Translational Medicine associated with Theophylline

100 Patents (Medical) associated with Theophylline

19,382

Literatures (Medical) associated with Theophylline

01 Feb 2025·Food Chemistry

Metabolic function and quality contribution of tea-derived microbes, and their safety risk in dark tea manufacture

Review

Author: Cheng, Lizeng ; Yu, Xiaoping ; Zhu, Yuzhi ; Xu, Lurong ; Peng, Lanlan ; Wei, Xinlin

Microbial fermentation, especially the microbes involved, plays a crucial role in the quality formation of dark tea. Over the last decade, numerous microbes have been isolated from dark tea and in turn, applied to dark tea manufacture through pure-strain, mixed-strain, and enhanced fermentation. This article systematically summarizes the specific metabolic function and quality contribution of tea-derived microbes, with special attention paid to their safety risk. Aspergillus niger converts catechins via hydrolysis, addition, oxidative polymerization, and B-ring fission, contributing greatly to the reddish-brown color and mellow taste of dark tea. Aspergillus sydowii and Penicillium simplicissimum are caffeine-degrading microbes, degrading caffeine mainly into theophylline. However, under adverse conditions, Aspergillus, Penicillium, and Fusarium species potentially produce aflatoxins, ochratoxin A, and citrinin, the mycotoxins occurring in dark tea. The in-depth knowledge of tea-derived microbes is important for improving the quality and safety of dark tea, providing a theoretical basis for its industrial modernization.

01 Jan 2025·Food Chemistry

Isolation, purification, characterization and stability analysis of melanin pigment from Mesona chinensis

Article

Author: Wang, Zhiao ; Zhao, Yingting ; Zhu, Hongzhang ; Xu, Ye ; Chen, Xinliang ; Tian, Yuting ; Zhao, Can ; Huang, Yuhua ; Cheng, Yuxin

In this study, the isolation and purification of melanin pigment from Mesona chinensis (MCM) were conducted, and the structural characterization and stability evaluation of MCM were performed. The results indicate that MCM is consistent with the spectral features of catechins and polyphenols, identified the stretching vibrations of functional groups such as OH, CH, CO, and CO. It is inferred that the structure of MCM is consistent with that of theophylline and it is mainly composed of phenolic acids, terpenoids, and organic acids. Stability evaluations indicate that MCM exhibits stability under white light, ultraviolet (UV) light, neutral, and alkaline environments, and it shows low sensitivity to reducing agents.

01 Jan 2025·Analytical Biochemistry

An RNA aptamer photoelectrochemical biosensor based on the exciton energy transfer constructed for theophylline detection

Article

Author: Zhu, Gang ; Feng, Dexiang ; Wei, Yan ; Chen, Jiexia ; Li, Lihua ; Liu, Zhuoer ; Zhang, Chuanqi ; Lu, Yilin

A novel photoelectrochemical (PEC) biosensor was developed incorporating a specifically designed RNA aptamer for the detection of theophylline (TP). This involved utilizing two nucleotide base aptamers with tailored sequences designed to target TP. The 3' end of a single-stranded RNA sequence (5'-GGAUACCA-(CH₂)₆-SH-3') and the 5' end of a complementary stranded RNA sequence (5'-HS-(CH₂)₆-CCUUGGAAGCC-3') were linked to gold nanoparticles (AuNPs) and CdS quantum dots (QDs), respectively. These two single-stranded RNAs (ssRNA) formed a double-stranded RNA (dsRNA) capable of recognizing TP. This major structural change altered the spacing between QDs and NPs, which signaled the presence and concentration of TP. TP was photoelectrochemical catalytic oxidation by the hole of CdS QDs under illumination, then anode photocurrent was generated. Due to the increase in surface impedance and the effect of exciton energy transfer (EET) between QDs and AuNPs, the photocurrent would undergo varying degrees of change. TP was detected by changes in photocurrent. PEC detection of TP was achieved in the range of 0.1 μM-200 μM. The detection limit was 0.033 μM. The method exhibited commendable reproducibility and remarkable selectivity. The biosensor was used to measure TP content in tea, beverages and blood samples, resulting in satisfactory recovery rates.

News (Medical) associated with Theophylline

12 Nov 2024

·www.globenewswire.com

Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)

MORRISTOWN, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for OCALIVA® (obeticholic acid, OCA) seeking full approval for the treatment of indicated patients with primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In its letter, the FDA also said it was continuing to consider safety data from Study 747-302, along with other safety information. OCALIVA continues to be available for the treatment of appropriate patients living with PBC in the U.S. under accelerated approval status. Healthcare professionals who have questions about OCALIVA can contact Intercept Medical Information, and patients with questions should contact their healthcare providers. “We believe in the totality of evidence supporting OCALIVA and intend to work closely with the FDA on next steps,” said Vivek Devaraj, U.S. President and Chairman at Intercept. “We remain committed to patients living with PBC who have limited treatment options.” OCALIVA’s safety profile is based on extensive data from long-term clinical-trials, published real-world evidence and external-control studies, as well as 8 years of post-marketing patient experience that collectively spans 42,000 patient years. About Primary Biliary CholangitisPrimary biliary cholangitis (PBC) is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately 1 in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant, or death. About InterceptIntercept is a biopharmaceutical company and a wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, including primary biliary cholangitis (PBC) and severe alcohol-associated hepatitis (sAH). Intercept owns the commercial rights to OCALIVA in the U.S. market. For more information, please visit www.interceptpharma.com or connect with the Company on LinkedIn, Threads and X (formerly Twitter). About Ocaliva® (obeticholic acid) OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis. OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension, or experience clinically significant hepatic adverse reactions while on treatment. Contraindications OCALIVA is contraindicated in patients with: decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) complete biliary obstruction Warnings and Precautions Hepatic Decompensation and Failure in PBC Patients with Cirrhosis Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in PBC patients with cirrhosis, either compensated or decompensated. Among post-marketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decompensated cirrhosis. Some of these cases occurred in patients with decompensated cirrhosis when they were treated with higher than the recommended dosage for that patient population; however, cases of hepatic decompensation and failure have continued to be reported in patients with decompensated cirrhosis even when they received the recommended dosage. Hepatotoxicity was observed in the OCALIVA clinical trials. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease), and/or with severe intercurrent illness for new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or increases above the upper limit of normal in total bilirubin, direct bilirubin, or prothrombin time to determine whether drug discontinuation is needed. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patient’s liver function. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment. Severe Pruritus Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. Reduction in HDL-C Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in OCALIVA-treated patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor patients for changes in serum lipid levels during treatment. For patients who do not respond to OCALIVA after 1 year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment. Adverse Reactions The most common adverse reactions (≥5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. Drug Interactions Bile Acid Binding Resins Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA. If taking a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible. Warfarin The International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when co-administering OCALIVA and warfarin. CYP1A2 Substrates with Narrow Therapeutic Index Obeticholic acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with OCALIVA. Inhibitors of Bile Salt Efflux Pump Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin. Please click here for Full Prescribing Information, including Boxed WARNING. To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ContactFor more information about Intercept, please contact:For media:media@interceptpharma.com

Accelerated ApprovalClinical ResultClinical Study

17 Oct 2024

·www.globenewswire.com

Intercept Provides Regulatory Update Regarding sNDA for OCALIVA

MORRISTOWN, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned subsidiary of Alfasigma S.p.A., today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it is continuing its review of the supplemental New Drug Application (sNDA) for full approval of OCALIVA® (obeticholic acid, OCA) for the treatment of indicated patients with primary biliary cholangitis (PBC), and its action under the Prescription Drug User Fee Act (PDUFA), expected on October 15, 2024, has been delayed. The FDA did not provide a new anticipated action date. OCALIVA remains available for the treatment of appropriate PBC patients in the U.S. under accelerated approval status. Healthcare professionals who have questions about OCALIVA can contact Intercept Medical Information, and patients with questions should contact their healthcare providers. “We will continue to engage with the FDA regarding our pending application,” said Vivek Devaraj, U.S. President and Chairman at Intercept. “We are grateful for the continuous and ongoing support of the PBC community.” About Primary Biliary CholangitisPrimary biliary cholangitis (PBC) is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately 1 in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant, or death. About InterceptIntercept is a biopharmaceutical company and a wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, including primary biliary cholangitis (PBC) and severe alcohol-associated hepatitis (sAH). Intercept owns the commercial rights to OCALIVA in the U.S. market. For more information, please visit www.interceptpharma.com or connect with the Company on LinkedIn, Threads and X (formerly Twitter). About Ocaliva® (obeticholic acid)OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis. OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension, or experience clinically significant hepatic adverse reactions while on treatment. Contraindications OCALIVA is contraindicated in patients with: decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) complete biliary obstruction Warnings and Precautions Hepatic Decompensation and Failure in PBC Patients with Cirrhosis Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in PBC patients with cirrhosis, either compensated or decompensated. Among post-marketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decompensated cirrhosis. Some of these cases occurred in patients with decompensated cirrhosis when they were treated with higher than the recommended dosage for that patient population; however, cases of hepatic decompensation and failure have continued to be reported in patients with decompensated cirrhosis even when they received the recommended dosage. Hepatotoxicity was observed in the OCALIVA clinical trials. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease), and/or with severe intercurrent illness for new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or increases above the upper limit of normal in total bilirubin, direct bilirubin, or prothrombin time to determine whether drug discontinuation is needed. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patient’s liver function. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment. Severe Pruritus Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. Reduction in HDL-C Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in OCALIVA-treated patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor patients for changes in serum lipid levels during treatment. For patients who do not respond to OCALIVA after 1 year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment. Adverse Reactions The most common adverse reactions (≥5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. Drug Interactions Bile Acid Binding Resins Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA. If taking a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible. Warfarin The International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when co-administering OCALIVA and warfarin. CYP1A2 Substrates with Narrow Therapeutic Index Obeticholic acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with OCALIVA. Inhibitors of Bile Salt Efflux Pump Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin. Please click here for Full Prescribing Information, including Boxed WARNING. To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ContactFor more information about Intercept, please contact:For media:media@interceptpharma.com

Accelerated ApprovalClinical ResultClinical Study

24 Sep 2024

·www.globenewswire.com

Busy Philipps Encourages Women to Take Charge of Their ADHD This Fall in Ongoing Collaboration with Supernus Pharmaceuticals and Qelbree

Ahead of ADHD Awareness Month, Busy is sharing her ADHD diagnosis and Qelbree® (viloxazine extended-release capsules) treatment story to empower women living with ADHD to advocate for their care.ADHD often presents differently in women than in men, which can make it more challenging to recognize in women and ultimately leaving them undiagnosed and untreated.1 ROCKVILLE, Md., Sept. 24, 2024 (GLOBE NEWSWIRE) -- In a continued collaboration with Supernus Pharmaceuticals, actress, author, podcaster, late-night host, and mom, Busy Philipps, is speaking up this fall about her ongoing journey with attention-deficit/hyperactivity disorder (ADHD), bringing awareness to the often-overlooked symptoms of the condition in women and Qelbree, a non-stimulant ADHD treatment that has benefitted her. With summer over and the school year now in full swing, the fall season brings for many adults a return to normal routines or schedules, as well as an opportunity for a fresh start. Busy knows first-hand just how difficult getting ‘back to schedule’ can be for the approximately 10 million adults living with ADHD, who may be experiencing symptoms of inattention, hyperactivity/impulsivity, or both.2 She’s sharing her story to help empower people, and especially women, living with ADHD to take action for a fresh start this fall and talk to their doctors about treatment options to help manage their condition. “For many years living with unmanaged ADHD, I’d often start a task and never remember to finish, frequently feeling restless and unable to stay still. I would ramble on, get easily distracted and have trouble multitasking, and with my busy lifestyle, it was a challenge,” says Busy. “Now that I’m taking Qelbree, I’m relieved that my ADHD symptoms are more manageable. I only wish I’d taken charge of my ADHD sooner. That’s why I’m sharing my story to raise awareness about ADHD and help others who may be struggling with their diagnosis find a treatment option that works for them like Qelbree has worked for me.” Qelbree is a novel, once-a-day, non-stimulant approach for patients 6 years and older with ADHD, and the first non-stimulant approved for adults with ADHD in 20 years. As a non-stimulant, Qelbree has no evidence of abuse or misuse and can be conveniently refilled without needing a new prescription each month. “As a leader in treating ADHD, Supernus is committed to providing treatment options and education to help people living with ADHD like Busy Philipps manage their ADHD symptoms,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We appreciate Busy’s continued support and willingness to share her ADHD story and experience with Qelbree, especially leading into ADHD Awareness Month.” For more information about Qelbree, visit Qelbree.com. Patients should speak to a doctor about all the medications they take, and to see if Qelbree could be right for them. INDICATION Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATION Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. You or your child should not take Qelbree if you or your child: Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline. Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs. Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania. Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired. The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning, for Qelbree here. 1Holthe, M. E. G., Langvik, E. (2017). The Strives, Struggles, and Successes of Women Diagnosed with ADHD as Adults. SAGE Journals. 2Culpepper, L., Mattingly, G. (2010). Challenges in Identifying and Managing Attention-Deficit/Hyperactivity Disorder in Adults in the Primary Care Setting: A Review of the Literature. Primary Care Companion Journal of Clinical Psychiatry. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. CONTACTS: Jack A. Khattar, President and CEO Timothy C. Dec, Senior Vice President and CFO Supernus Pharmaceuticals, Inc. Tel: (301) 838-2591 Or INVESTOR CONTACT: Peter Vozzo ICR Westwicke Office: (443) 213-0505 Email: Peter.Vozzo@westwicke.com MEDIA CONTACT: Matthew FrappierTel: (646) 358-9683Email: Matthew.Frappier@bcw-global.com

Drug Approval

100 Deals associated with Theophylline

External Link

KEGG	Wiki	ATC	Drug Bank
D06103	Theophylline	R03DA04	DB00277

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthmatic bronchitis	JP	Mitsubishi Tanabe Pharma Corp.	01 Apr 1984
Bronchitis, Chronic	JP	Mitsubishi Tanabe Pharma Corp.	01 Apr 1984
Pulmonary Emphysema	JP	Mitsubishi Tanabe Pharma Corp.	01 Apr 1984
Asthma	GB	Mylan, Inc.	22 Jan 1980

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Altitude Sickness	Discovery	CN	The University of Montana	18 Jul 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03984188 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive \| Respiration Disorders	100	Standard of Care Treatment+Theophylline ER (Low-dose Theophylline Group)	ltiwcszllb(zxmzhrljzx) = rhwmoirydp wjaihgujnv (dmjtpsvkrm, ffazlibujn - ktiydynafo) View more	-	29 Oct 2024
				Standard of Care Treatment (Placebo Group)	ltiwcszllb(zxmzhrljzx) = ldxtmqmrmx wjaihgujnv (dmjtpsvkrm, mdrnzodsfc - ruagdbyxqp) View more
NCT02479451 (HONORR, CTgov)	Phase 2	Kidney Failure, Chronic \| Olfactory Nerve Diseases	7	Theophylline	mfszlvmcuq(kgxfgkyvfk) = qiyxevyolj qqrlrpfzuw (xxozfrkrcm, cbsolhheke - bvoxkktcvr) View more	-	09 Jan 2024
NCT04789499 (SCENT2, CTgov)	Phase 2	COVID-19 \| Ageusia \| Anosmia \| Olfactory Nerve Diseases	51	Theophylline Powder (Theophylline)	(cmimdmqxbj) = lthqgeuoeo ghmurkldzm (eovwdoofou, sdjbqwltdg - piilrocmvf) View more	-	24 May 2023
				Placebo Comparator (Placebo)	(cmimdmqxbj) = ssmnniifvg ghmurkldzm (eovwdoofou, fisyurnuel - spewgwohts) View more
NCT02261727 (TASCS, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	1,670	Placebo (for Theophylline) (Placebo)	mtctwvmfnm(pwfqojiaob) = bawjfhkoot bfitrevgob (mzmczxsgqc, xamsrkmzow - vjhaammsnt) View more	-	12 Aug 2021
				Placebo (for prednisone)+Theophylline (Low-dose Theophylline Arm)	mtctwvmfnm(pwfqojiaob) = bqgbtlklai bfitrevgob (mzmczxsgqc, orylroqdje - afrqlcoces) View more
NCT00241631 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	49	placebo+Theophylline (Placebo)	qxlrpbhbte(yrouptbyjb) = fgxwsnhhzy hqirqqgdip (zaezqwbdkp, tmydquanqh - ylfbkprfoo) View more	-	04 Dec 2019
				Theophylline+Fluticasone Propionate (Steroid)	qxlrpbhbte(yrouptbyjb) = nksgbrapiy hqirqqgdip (zaezqwbdkp, ildudtgyfa - drrrtpkjra) View more
Pubmed \| Int J Cardiol	Not Applicable	Syncope	16	Theophylline	nbrhruqisp(jigdavvkmo) = bpestqjrnk kkapnnjqnv (zbmbdgnqgo ) View more	Positive	01 Aug 2019
ASN2018	Not Applicable	Perinatal asphyxia	116	Theophylline	iwsyydimon(bsonuxgfjv) = ysqcyundoo pcgyeonfkl (jlkowhqgqo )	Negative	23 Oct 2018
				No Theophylline	iwsyydimon(bsonuxgfjv) = jaosvupzpz pcgyeonfkl (jlkowhqgqo )
ISRCTN27066620 (TWICS, Pubmed \| J Coll Physicians Surg Pak)	Not Applicable	Pulmonary Disease, Chronic Obstructive	1,578	Low-dose Theophylline	(zcibjaxdxa) = mfssqywxhs ymhucpccme (yyuixirwep, 2.10 - 2.38)	Negative	16 Oct 2018
				Placebo	(zcibjaxdxa) = tawqkhhgfq ymhucpccme (yyuixirwep, 2.09 - 2.37)
NCT02340520 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	13	Theophylline+Roflumilast	rumuqazubp(nvhnutvupa) = cveorgwatb osssgpwmto (hignkrfgjh, bedzudxymu - ynvqeqiqhv) View more	-	19 Jun 2018

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