FDA approves Azurity’s Nymalize oral solution in prefilled syringe

The oral solution in the prefilled ENFit syringe offers a safer alternative for adult subarachnoid haemorrhage patients.

Vishnu Priyan September 04 2024

Azurity Pharmaceuticals’ Nymalize (nimodipine) oral solution in a 30mg/5ml prefilled ENFit syringe has received US Food and Drug Administration (FDA) approval.

The ready-to-use prefilled syringe offers an additional layer of security for both patients and healthcare professionals when administering medication.

The oral solution in the prefilled ENFit syringe offers an effective alternative for adult subarachnoid haemorrhage patients who are unable to swallow capsules.

The adoption of ENFit connectors, which are recommended by the FDA, is said to be on the rise, with around 60% of acute care facilities in the US making the switch from traditional nasogastric tubing.

Nymalize improves neurological outcomes by reducing the incidence and severity of ischemic deficits in adults with subarachnoid haemorrhage from ruptured intracranial berry aneurysms.

It is suitable for patients across a range of post-ictus neurological conditions, classified from Hunt and Hess Grades I to V.

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

Azurity Pharmaceuticals CEO Richard Blackburn stated: “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.”

In September 2022, the FDA granted approval for Azurity’s Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcers.

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