The FDA has approved Neurelis’s Valtoco diazepam nasal spray for the treatment of seizure clusters or acute repetitive seizures in epilepsy patients aged 6 years and older. Neurelis submitted the 505(b)(2) NDA for Valtoco in September 2018.
Valtoco, which was formerly known as NRL-1, was granted orphan drug designation in December 2015 and Fast Track designation in December 2016. The Valtoco formulation includes Intravail, a transmucosal absortion enhancer developed by Aegis Therapeutics, which was acquired by Neurelis in December 2018.
In November 2019, Aquestive Therapeutics, which is developing a diazepam buccal film, filed a citizen petition with the FDA asking that the agency delay approval of the Valtoco nasal spray, suggesting that “The existing clinical studies for Valtoco demonstrate considerable pharmacokinetic (“PK”) variability and do not support the development of robust and adequate labeling for the product.” According to Aquestive, the company received a response letter from the FDA dated January 10, 2020 which said that the agency had approved Valtoco that same day.
Aquestive CEO Keith J. Kendall commented, “We appreciate that the FDA has confirmed in the response its guidance that 505(b)(2) drugs can be approved without proving bioequivalence if they demonstrate ‘relative bioavailability’ to the reference drug. The FDA stated in the response, when granting exclusivity based upon ‘major contribution to patient care’ over and above already approved products for the indication, it may consider such factors as convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease and comfort of drug administration, longer periods between doses, and potential for self-administration. In making this determination for Valtoco, the FDA indicated in the response that the intranasal route of administration provides a major contribution to patient care over the rectal route of administration by providing a significantly improved ease of use.”
Neurelis President and CEO Craig Chambliss said, “Cluster or acute repetitive seizures are challenging to treat and highly disruptive in the lives of people with epilepsy. Valtoco was developed to provide an effective combination of reliability, safety and tolerability in a ready-to-use nasal spray. This is a defining moment for Neurelis as Valtoco is our first FDA-approved product. We are excited that we can now offer this treatment option to patients and provide additional support to the epilepsy community.”
Read the Neurelis press release.
Read the Aquestive Therapeutics press release.
