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Recro Pharma Provides Pipeline Update

IV Meloxicam Advancing to Phase III; Pivotal Trials Expected to Commence in First Quarter 2016

Company Shifts Focus of Dex-IN to Peri-Procedural Pain Indication

MALVERN, Pa., Oct. 26, 2015 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (REPH), a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of acute pain, today provided a clinical and regulatory update on its pipeline candidates. In the first quarter of 2016, the Company intends to initiate a pivotal Phase III clinical development program with IV meloxicam, a long-acting, preferential COX-2 inhibitor, for the treatment of moderate to severe acute post operative pain. For Dex-IN, Recro's intranasal formulation of the selective alpha-2 agonist analgesic, dexmedetomidine, the Company plans to continue to study Dex-IN in painful conditions with a focus on the treatment of peri-procedural pain.

"The decision to advance IV meloxicam into Phase III is an important milestone for Recro and we are excited about the opportunity this candidate represents as a new option for moderate to severe pain in the acute, post operative setting," said Gerri Henwood, Recro Pharma's President and Chief Executive Officer. "Following the successful submission and review of additional FDA requested clinical and nonclinical information and the availability of new clinical drug supply, we expect to initiate the Phase III trials during the first quarter of 2016."

Ms. Henwood continued: "Following our recent discussion with the FDA, we believe the Dex-IN product profile is better suited for peri-procedural pain rather than the post op setting evaluated in our Phase II trial. We are working to design an appropriate Phase II program to evaluate Dex-IN in this patient population. We believe this approach provides the best path forward for this candidate, and we look forward to providing future updates as we progress."

IV Meloxicam for the Treatment of Moderate to Severe Acute Pain

Recro recently met with the U.S. Food and Drug Administration (FDA) to obtain feedback for its proposed IV meloxicam Phase III clinical development program. Based on feedback from the FDA, the Company intends to initiate a Phase III program with IV meloxicam. Recro expects that the Phase III program will include two pivotal clinical trials, as well as other trials. We expect to enroll a total of approximately 1,300 patients in all these trials. One pivotal clinical trial will be designed to demonstrate pain relief over a 48-hour period in a...


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