FDA Approves Azurity's Nymalize Prefilled Syringe Solution

Azurity Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for its Nymalize (nimodipine) oral solution, now available in a 30 mg/5 ml prefilled ENFit syringe. This development provides an added layer of safety for both patients and healthcare providers during medication administration.

The prefilled ENFit syringe offers a practical and effective alternative for adult patients suffering from subarachnoid haemorrhage who are unable to swallow capsules. The ENFit connectors, which have been recommended by the FDA, are increasingly being adopted, with approximately 60% of acute care facilities in the U.S. transitioning away from traditional nasogastric tubing to this new system.

Nymalize is specifically indicated for adults who have experienced subarachnoid haemorrhage due to ruptured intracranial berry aneurysms. The medication is designed to improve neurological outcomes by reducing the frequency and severity of ischemic deficits, which are common in such conditions. Patients with a variety of post-ictus neurological conditions, classified under Hunt and Hess Grades I to V, can benefit from this treatment.

The prefilled ENFit syringes (30 mg/5 ml) will soon be available for order through pharmaceutical wholesalers, along with other formats such as prefilled oral syringes (30 mg/5 ml and 60 mg/10 ml) and 8 oz (237 ml) bottles.

Azurity Pharmaceuticals' CEO, Richard Blackburn, emphasized the company’s dedication to patient care by stating, “Patients are our priority, and our purpose is to bring them new formulations and delivery systems that help them benefit from established medicines. Delivering Nymalize with ENFit syringes may offer patients and healthcare professionals a more secure, reliable drug administration through standardisation.”

This approval highlights Azurity Pharmaceuticals' commitment to enhancing drug delivery methods to ensure improved patient outcomes and safety.