FDA Approves Nymalize in Prefilled ENFit Syringes

The FDA has granted approval to nimodipine (Nymalize) oral solution in 30 mg/5 mL prefilled ENFit syringes, Azurity Pharmaceuticals announced in a release.¹ The ready-to-use prefilled ENFit syringes can provide an added layer of security to patients and health care providers who are administering medications.

FDA Approves Nymalize in Prefilled ENFit Syringes / monticellllo - stock.adobe.com

Nymalize, which was initially approved by the FDA in 2013, 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. Aside from the new ENFit syringes, the medication is available in prefilled oral syringes and in 8 oz bottles.²

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“Patients are our priority, and our purpose is to bring them new formulations and delivery systems that help them benefit from established medicines,” Richard Blackburn, CEO of Azurity Pharmaceuticals, said in a release.¹ “Delivering Nymalize with ENFit syringes may offer patients and healthcare professionals a more secure, reliable drug administration through standardization.”

Due to continued reports of misconnections with enteral devices, the FDA has recommended that hospitals and clinicians use enteral devices with connectors, many of which are identified as ENFit. Misconnections between enteral devices and other medical devices can result in serious injuries or death. From 2011 to 2018, 2 deaths, 24 serious injuries, and 32 device malfunctions related to enteral misconnections were reported to the FDA. However, the agency said many misconnections are likely not reported.³

There has already been widespread adoption of ENFit connectors, which have begun to replace traditional nasogastric tubing. According to data from the Global Engineered Device Supplier Association, it is estimated that 60% of acute care facilities in the United States have adopted ENFit connectors.⁴

Nymalize is an effective alternative to capsule extraction for adult patients with subarachnoid hemorrhage who are unable to swallow capsules. Azurity said in the release that Nymalize prefilled ENFit syringes will be available for order through a pharmaceutical wholesaler in the coming weeks.

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References

1. AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF NYMALIZE® (NIMODIPINE) ORAL SOLUTION 30 MG/5 ML PREFILLED ENFIT® SYRINGE. News Release. Azurity. September 3, 2024. Accessed September 6, 2024. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-nymalize-nimodipine-oral-solution-30-mg-5-ml-prefilled-enfit-syringe/

2. Determination That NYMALIZE (nimodipine), Oral Solution, 3 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Report. FDA. February 17, 2021. Accessed September 6, 2024. https://www.federalregister.gov/documents/2021/02/17/2021-03083/determination-that-nymalize-nimodipine-oral-solution-3-milligramsmilliliter-was-not-withdrawn-from

3. The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury. FDA. Release. September 7, 2018. Accessed September 6, 2024. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/115846/download

4. ENFit Global Adoption Status. GEDSA. Report. Accessed September 4, 2024. https://stayconnected.org/global-conversion/