AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF
NYMALIZE^® (NIMODIPINE) ORAL SOLUTION 30 MG/5 ML PREFILLED ENFIT^® SYRINGE

WOBURN, Mass. (September 3, 2024) – Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Nymalize^® (nimodipine) oral solution in a 30 mg/5 mL prefilled ENFit^® syringe.

“Patients are our priority, and our purpose is to bring them new formulations and delivery systems that help them benefit from established medicines,” said Richard Blackburn, CEO of Azurity Pharmaceuticals. “Delivering Nymalize with ENFit syringes may offer patients and healthcare professionals a more secure, reliable drug administration through standardization.”

The Nymalize 30 mg/5 mL prefilled ENFit syringe may provide an additional layer of security for patients and healthcare professionals administering medication.^1-3 ENFit connectors are recommended by the FDA and widespread adoption of ENFit has begun to replace traditional nasogastric tubing.^4-6 Approximately 60% of all acute care facilities in the USA have adopted ENFit.⁵

Nymalize offers an effective alternative to capsule extraction for adult subarachnoid hemorrhage patients who cannot swallow capsules. Nymalize is available in ready-to-use prefilled ENFit syringes (30 mg/5 mL), prefilled oral syringes (30 mg/5 mL and 60 mg/10 mL) and in 8 oz (237 mL) bottles. Nymalize may help reduce the risk of fatal medication errors associated with nimodipine capsule extraction.

Nymalize is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I–V).

The Nymalize prefilled ENFit syringe will be available to order through a pharmaceutical wholesaler in the coming weeks. For important safety information and full prescribing information, please visit www.nymalize.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 cardiovascular, central nervous system, endocrine, gastro-intestinal, anti-infective, 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 www.azurity.com.

References:

1. Stay Connected User Benefits of the ENFit® Enteral Feeding System https://stayconnected.org/user-benefits-of-the-enfit-enteral-feeding-system/.
2. U.S. Food & Drug Administration, Examples of Medical Device Misconnections https://www.fda.gov/medical-devices/medical-device-connectors/examples-medical-device-misconnections.
3. Stay Connected ENFit® Pharmacy Resource https://stayconnected.org/pharmaguide/.
4. FDA. The FDA encourages use of enteral device connectors that reduce risk of misconnection and patient injury. Accessed May 1, 2024. https://www.fda.gov/media/115846/download
5. ENFIT Global Conversion Updates & Map. Stay Connected® by GEDSA. 2023. Accessed June 26, 2024. https://stayconnected.org/global-conversion/
6. GEDSA US conversion rates flyer 2023. Stay Connected® by GEDSA. 2023. Accessed June 26, 2024. https://stayconnected.org/gedsausconversionratesflyer2023

Nymalize^® is a registered trademark of Azurity Pharmaceuticals, Inc. ENFit^® is a registered trademark of Global Enteral Device Supplier Association, Inc.

Contact: Azurity Pharmaceuticals Media Relations
Email: media@azurity.com

PP-MYH-US-0006