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FDA Issued a Complete Response Letter Regarding Osmotica Pharmaceuticals (OSMT) New Drug Application

Osmotica Pharmaceuticals plc (NASDAQ: OSMT) stock was trading -8.63% away from 20 day Simple Moving Average. The company’s weekly performance was -8.16% in contrast to the annual performance of 22.66%. The healthcare sector giant has total of 379 employees on its payroll and the Market capitalization of 342.10M.

The FDA has issued a Complete Response Letter (CRL) regarding Osmotica Pharmaceuticals plc (Nasdaq: OSMT) New Drug Application (NDA) for arbaclofen extended release (ER) tablets to treat spasticity caused by multiple sclerosis.

The CRL pointed out that the company has not provided adequate justification for comparing arbaclofen 40 mg to placebo (despite the company’s most recent amendment to their NDA), which was one of the primary endpoints. In its CRL, the FDA suggested that the Company conduct a new study to provide substantial evidence of the efficacy of arbaclofen.

Brian Markison, CEO of Osmotica stated that, we think we have adequately supported both the efficacy and safety of both the 40 mg/day and 80 mg/day doses of arbaclofen. Osmotica believes its safety and efficacy database for both strengths of arbaclofen proves there is an enormous unmet demand for better treatments for MS patients who experience spasticity.
We intend to review the CRL with our advisors and to meet with the FDA to discuss their recommendations, He added.

Osmotica Pharmaceuticals plc develops and commercializes specialty products that target markets with underserved patient populations. RVL Pharmaceuticals, Inc. is the Company’s ophthalmic subsidiary that supports UPNEEQ. The company’s branded portfolio is represented by Vertical Pharmaceuticals, LLC and its non-promoted products, such as complex generic formulations, are represented Trigen Laboratories, LLC.

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