Osmotica Pharma Obtains CRL From FDA For Arbaclofen Extended Release Tablets; Stock Plunges

(RTTNews) - Osmotica Pharmaceuticals plc (OSMT) said Tuesday that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding the company's New Drug Application. The NDA seeks approval for the investigational agent arbaclofen extended release tablets to treat spasticity resulting from multiple sclerosis.

OSMT closed Tuesday regular trading at $5.29, down $0.58 or 9.88 percent. In the after-hours trading, the stock further dropped $1.30 or 24.57 percent.

The CRL stated that the company did not provide adequate justification--including in its most recent NDA amendment-- for the statistical analysis of the change from baseline to Day 84 in TNmAS-MAL scores comparing arbaclofen 40 mg to placebo, one of the co-primary endpoints.

The FDA made a number of recommendations in its CRL, including that the company conduct a new study in order to provide substantial evidence of efficacy of arbaclofen.

The company said it plans to review the CRL with its advisors and to request a meeting with the FDA to discuss their recommendations.