(Reuters) – Axsome Therapeutics said on Monday it expects the U.S. health regulator to decline approval for its acute treatment of migraine, as issues around its quality control processes were unresolved.
The drug developer’s shares fell 23% to $30 in premarket trading.
The U.S. Food and Drug Administration is expected to make its decision on the drug, AXS-07, by Saturday.
Axsome’s submission, accepted by the FDA in September, was based on two late-stage clinical trials that showed usage of the drug led to significant elimination of migraine pain compared with placebo and active controls.
The company said https://www.sec.gov/ix?doc=/Archives/edgar/data/0001579428/000095017022006038/axsm-20220422.htm on Monday that chemistry, manufacturing and controls issues were identified during the FDA’s review of the drug.
The therapy consists of two compounds, meloxicam and rizatriptanx, which help in reducing symptoms such as headache and nausea. It works by inhibiting the release of specific amino acids that carry cues to different cells, thereby stopping neuroinflammation and transmission of pain signals.
An FDA decision against approval will mark another setback for the company, which has a drug to treat major depressive disorder awaiting approval.
The U.S. regulator notified the company of certain deficiencies in its application for depression drug AXS-05 ahead of its earlier target action date of Aug. 22 last year. The company provided its response in January.
(Reporting by Leroy Leo in Bengaluru; Editing by Amy Caren Daniel)
