Diazepam Granted Fast Track, Nerivio Receives FDA Clearance, Zolmitriptan Gets CRL Following NDA Submission

This week Neurology News Network covered the fast track designation granted to diazepam non-aqueous injection, the FDA clearance of the Nerivio medical device, and details on the complete response letter Zosano Pharma received in relation to zolmitriptan's new drug application.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Xeris Pharmaceuticals announced that its investigational treatment, diazepam non-aqueous injection, also known as XP-0863, was granted fast track designation by the FDA for the treatment of acute repetitive seizures. The complete results of the company’s phase 1b study were shared with the FDA as well, to which the agency responded by informing Xeris it may directly advance diazepam into a phase 3 registration study in both pediatric and adult patients with epilepsy. “The FDA’s fast track designation highlights the clear unmet need in treating acute repetitive seizures with the preparations of diazepam available today and highlights our opportunity to dramatically improve care through the introduction of a ready-to-use injection formulation,” Paul R. Edick, chairman and chief executive officer, Xeris. This Xeris formulation of diazepam is yet another variation of the agent making its way through the clinical and regulatory process. In January 2020, the FDA approved an intranasal diazepam formulation (Valtoco; Neurelis) for the treatment of acute intermittent, stereotypic episodes of frequent seizure activity, becoming the first nasal spray approved as rescue medication in patients 6 years and older with epilepsy.

Theranica Biotherapeutics has announced that its Nerivio medical device has received clearance from the FDA for an expansion on its treatment indication to include the acute treatment of chronic migraine in patients aged 18 years and older.This new indication means the device is now cleared to use in the acute treatment of migraine with or without aura in individuals aged 18 years or older, regardless of episodic or chronic migraine classification. The FDA’s decision was made based on the results of 2 clinical studies in chronic migraine. Stephen Silberstein, director, Headache Center, Jefferson University Hospital, said in a statement, “The updated Nerivio indication is an important development for patients with chronic migraine. When chronic patients find an effective treatment, they must limit its use every month to avoid loss of effectiveness and a risk of medication overuse headache. [The] availability of an additional treatment option such as Nerivio provides an important additional tool to address this patient population.

Zosano Pharma announced that it has received a complete response letter from the FDA for its zolmitriptan transdermal microneedle system (Qtrypta) in correlation with the new drug application it had submitted. Inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies which had been previously identified in the FDA’s discipline review letter (DRL) in September, were among the main reasons cited for the CRL. The CRL also noted differences in the exposure levels of zolmitriptan observed between subjects who received different lots of the drug in the company’s trials as well as inadequate pharmacokinetic bridging between the lots that made the interpretation of some safety data unclear. Zolmitriptan, a treatment for acute migraine also known as its adhesive dermally applied microarray (ADAM) platform, had its NDA accepted by the FDA in March 2020 with an original PDUFA action date of October 20, 2020, which since then has been rescheduled.

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