Azurity Pharma Announces FDA Approval of Nymalize® Oral Solution Prefilled Enfit® Syringe

Azurity Pharmaceuticals, based in Woburn, Massachusetts, has announced that the FDA has approved their new Nymalize® (nimodipine) oral solution, now available in a 30 mg/5 mL prefilled ENFit® syringe. Azurity focuses on creating innovative formulations and dose forms to meet the needs of patients who are often overlooked.

Richard Blackburn, CEO of Azurity Pharmaceuticals, emphasized the company's commitment to patient care, stating, “Our goal is to introduce new formulations and delivery systems that enhance the benefits of established medications.” He noted that the use of ENFit syringes for administering Nymalize could provide a more secure and standardized method for both patients and healthcare providers.

The new Nymalize prefilled ENFit syringe is expected to increase the safety and reliability of drug administration. ENFit connectors have been recommended by the FDA to replace traditional nasogastric tubing, with about 60% of acute care facilities in the U.S. having adopted the ENFit system.

Nymalize serves as a crucial alternative for adult patients with subarachnoid hemorrhage who are unable to swallow capsules. The medication is now available in various forms, including the 30 mg/5 mL prefilled ENFit syringe, prefilled oral syringes (both 30 mg/5 mL and 60 mg/10 mL), and 8 oz (237 mL) bottles. This innovation could help minimize the risk of fatal medication errors that can occur with nimodipine capsule extraction.

Nymalize is specifically indicated for improving neurological outcomes by reducing the incidence and severity of ischemic deficits in adult patients suffering from subarachnoid hemorrhage due to ruptured intracranial berry aneurysms, regardless of their initial neurological condition.

The Nymalize prefilled ENFit syringe will soon be available for order through pharmaceutical wholesalers.

Azurity Pharmaceuticals is dedicated to delivering innovative, high-quality medicines tailored to the needs of patients with specific, often unmet, medical conditions. Their product range covers various therapeutic areas, including cardiovascular, central nervous system, endocrine, gastrointestinal, anti-infective, and oncology. Many of their medications are designed as dose-form innovations, making them particularly beneficial for patients who do not find adequate solutions among existing products. Azurity's medicines have positively impacted millions of patients.