Osmotica Pharmaceuticals plc Receives Complete Response Letter from U.S. Food and Drug Administration for Arbaclofen Extended Release Tablets
BRIDGEWATER, N.J., Dec. 29, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) regarding the Company's New Drug Application (“NDA”) seeking approval for the investigational agent arbaclofen extended release ("ER") tablets to treat spasticity resulting from multiple sclerosis.
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.
"We believe we have provided data supporting the efficacy and safety for both the 40 mg/day and 80 mg/day doses of arbaclofen. There is a tremendous unmet need for better treatments to help MS patients cope with spasticity, and we believe our safety and efficacy database for both strengths of arbaclofen provides a meaningful body of evidence that should support approval,” said Brian Markison, CEO of Osmotica.
The Company intends to review the CRL with its advisors and to request a meeting with the FDA to discuss their recommendations.
About Arbaclofen ER
Osmotica Pharmaceutical plc is developing arbaclofen (the active R-enantiomer of baclofen) ER tablets for the treatment of spasticity in patients with MS. This program aims to demonstrate the clinical efficacy and safety of arbaclofen ER tablets in patients with spasticity due to MS.
About Osmotica Pharmaceuticals plc
Osmotica Pharmaceuticals plc is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. RVL Pharmaceuticals, Inc. is the Company’s ophthalmic subsidiary supporting UPNEEQ. Vertical Pharmaceuticals, LLC represents the Company’s diversified branded portfolio and Trigen Laboratories, LLC represents the Company’s non-promoted products, including complex generic formulations.
Forward Looking Statements
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Investor and Media Relations for Osmotica Pharmaceuticals plc
Lisa M. Wilson
In-Site Communications, Inc.