Azurity Pharmaceuticals, a firm focused on creating new drug formulations for underserved patients, has received the US Food and Drug Administration (FDA) approval for Nymalize (nimodipine) oral solution.
Nymalize is now approved in a 30 mg/5 mL prefilled ENFit syringe.
The drug was developed by Arbor Pharmaceuticals which received FDA approval in 2013 for the improvement of neurological outcomes in adult patients with subarachnoid haemorrhage (SAH).
Arbor Pharmaceuticals was acquired and merged with Azurity Pharmaceuticals in 2021.
According to Azurity Pharmaceuticals, the prefilled ENFit syringe offers an added layer of safety for both patients and healthcare professionals administering medication.
ENFit connectors, recommended by the FDA, are meant to replace traditional nasogastric tubing.
The company reported that approximately 60% of acute care facilities in the US have adopted this new standard.
Nymalize provides a practical alternative for adult SAH patients who cannot swallow capsules.
It is available in several forms including prefilled ENFit syringes, prefilled oral syringes (30 mg/5 mL and 60 mg/10 mL), and 8 oz (237 mL) bottles.
The latest formulation may help mitigate the risk of potentially fatal medication errors linked to nimodipine capsule extraction, said the company.
Azurity Pharmaceuticals CEO Richard Blackburn said: “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.”
Nymalize is used to enhance neurological outcomes by decreasing ischemic deficits in adults with SAH from ruptured intracranial berry aneurysms. This is effective regardless of the patient’s post-ictus neurological condition.
The prefilled ENFit syringes are expected to be available for order through pharmaceutical wholesalers in the coming weeks.
Azurity Pharmaceuticals delivers a broad portfolio of treatments across various medical fields, including cardiovascular, central nervous system, endocrine, gastrointestinal, anti-infective, and oncology.
In May, the pharma company received FDA approval for Myhibbin. It is an antimetabolite immunosuppressant intended to protect a donated organ from being rejected by the body’s immune response.
