Azurity Pharmaceuticals, Inc.

WOBURN, Mass., Dec. 12, 2024 /PRNewswire/ -- Azurity Pharmaceuticals announced today the availability of Azmiro™, the first and only FDA-approved prefilled testosterone cypionate injection. Azmiro is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. "Azurity's purpose is to serve overlooked patients by developing innovative dose forms and formulations to serve unmet needs," said Richard Blackburn, CEO of Azurity Pharmaceuticals. "The commercial availability of Azmiro offers a convenient prefilled option for healthcare providers administering testosterone to patients." Testosterone cypionate intramuscular injections are commonly used as a testosterone replacement therapy for patients with low testosterone by drawing up testosterone cypionate doses from a vial, then administering with a syringe. Azmiro provides an FDA-approved prefilled option now available as a 200 mg/mL single dose syringe. Safety and efficacy of Azmiro in men with age-related hypogonadism have not been established. For full Azmiro prescribing information, including medication guide, please go to azmiro.com. About Azurity Pharmaceuticals, Inc. Azurity specializes in providing innovative, high-quality medicines that serve overlooked patients. We supply a large number of products to treat a wide range of medical conditions. These include anti-infective, cardiovascular/cardiology, central nervous system/cerebrovascular, endocrinology, gastrointestinal, immunology, and oncology medicines. Many of our medicines are dose-form innovations for patients with needs that are not met by other available products. Our medicines have benefited millions of people. For more information, visit . PP-AZO-US-0033 SOURCE Azurity Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Neonatal diabetes mellitus affects an estimated 300 individuals in the US. Credit: July Semianovich/Shutterstock. Eton Pharmaceuticals has acquired the US rights to Amglidia, a treatment developed for neonatal diabetes mellitus, from France-based biotechnology company AMMTeK. Amglidia, also known as glibenclamide in Europe, is a patented liquid product and was approved by the European Medicines Agency in 2018. The move is set to align with Eton Pharmaceuticals’ focus on paediatric endocrinology. The product also holds an orphan drug designation from the US Food and Drug Administration (FDA). AMMTeK’s post-approval study, which includes five years of real-world data on efficacy and safety from European subjects, is set to back Eton Pharmaceuticals’ new drug application submission. Eton Pharmaceuticals plans to meet with the FDA in the first quarter of 2025 and submit the NDA in 2026. Eton Pharmaceuticals CEO Sean Brynjelsen stated: “This exciting transaction adds another attractive, patented product candidate to our growing paediatric endocrinology portfolio. “The product aligns with Eton’s expertise and wealth of experience in bringing to market liquid and precision dose formulations for paediatric patients. Currently, there are no FDA-approved oral treatments for neonatal diabetes mellitus. “Amglidia has been used successfully to treat European patients for years, and families and paediatric endocrinologists have expressed to us the significant need for this treatment.” Neonatal diabetes mellitus affects an estimated 300 individuals in the US. Eton Pharmaceuticals acquired the US rights to PKU GOLIKE from Relief Therapeutics in March 2024. PKU GOLIKE is a medical formula product for the dietary management of phenylketonuria (PKU), using patented Physiomimic technology. In November 2021, the FDA approved Eton Pharmaceuticals and Azurity Pharmaceuticals’ Eprontia (topiramate) oral solution for seizures and migraine treatment.

Danziten is set to be available soon via Biologics by McKesson and Limited Specialty Distribution. Credit: Motortion Films via Shutterstock. The US Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals’ Danziten (nilotinib), the first and only nilotinib formulation that does not require mealtime restrictions, to treat chronic myeloid leukaemia (CML). It is indicated for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in the chronic phase, as well as those who are resistant or intolerant to previous therapies that included imatinib. Danziten’s reengineered formulation is said to provide equivalent efficacy to Tasigna but with enhanced bioavailability, enabling a lower dosage. Its approval is expected to enhance patient adherence to treatment, as it eliminates the need for fasting, which has been a challenge with current therapies. While Tasigna, the existing nilotinib treatment, has proven efficacy for Ph+ CML in chronic and acute phases, its bioavailability is affected by food intake, necessitating strict fasting to prevent cardiotoxicity. An optimal tyrosine kinase inhibitor therapy may lead to deep molecular responses, and for some patients, even treatment-free remission, the company noted. Azurity Pharmaceuticals CEO Richard Blackburn said: “Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna. “Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions.” Danziten is set to be shortly available via Biologics by McKesson and Limited Specialty Distribution. In September this year, the FDA approved the company’s Nymalize , an oral solution provided in a 5ml prefilled ENFit syringe as an alternative for adult subarachnoid haemorrhage patients. In 2022, it received approval for Konvomep, a treatment for active benign gastric ulcers and risk reduction of upper gastrointestinal bleeding in critically ill patients.