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recro pharma inc (RAH) Details

Recro Pharma, Inc., a clinical stage specialty pharmaceutical company, is engaged in the development of various non-opioid therapeutics for the treatment of pain and related conditions in the United States. The company is developing intranasal formulation of Dexmedetomidine (Dex) for the treatment of post-operative pain and cancer breakthrough pain; sublingual formulation of Dex for the treatment of chronic pain; and Fadolmidine (Fado), a product candidate to treat post-operative pain and neuropathic pain. It has a license agreement with Orion Corporation for the development and commercialization of Dex and Fado. The company was formerly known as Recro Pharma I, Inc. and changed its name to Recro Pharma, Inc. in August 2008. Recro Pharma, Inc. was founded in 2007 and is based in Malvern, Pennsylvania.

Founded in 2007

recro pharma inc (RAH) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $125.0K
Compensation as of Fiscal Year 2013.

recro pharma inc (RAH) Key Developments

Recro Pharma, Inc. Reports Unaudited Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014

Recro Pharma, Inc. reported unaudited earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, net loss applicable to common shareholders was $4,713,484 or $0.61 per basic and diluted share against $614,099 or $3.95 per basic and diluted share a year ago. For the nine months, net loss applicable to common shareholders was $13,923,398 or $2.42 per basic and diluted share against $1,901,095 or $12.22 per basic and diluted share a year ago.

Recro Pharma Announces Dosing of First Patient in Phase II REC-14-013 Clinical Trial of Dex-IN for Treatment of Acute Pain on Day 1 Following Surgery

Recro Pharma, Inc. announced dosing of the first patient in a Phase II clinical trial of Dex-IN in patients who initiate dosing of study medication on Post Op Day 1, following bunionectomy surgery. The Phase II trial is a randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of Recro Pharma's proprietary intranasal formulation of dexmedetomidine, Dex-IN, in adult patients undergoing bunionectomy surgery, initiating dosing of study medication on Post Op Day 1. The trial is expected to enroll approximately 200-250 patients. Patients who meet the eligibility criteria will be randomized to either a 50ug dose of Dex-IN or a placebo intranasal dose given every 6 hours. Following the beginning of treatment, patients will remain under observation for 48 hours at study centers. Patients will be followed for 7 days after the initial dose of study medication. There will be an oral opioid rescue treatment available to patients in either treatment group, if required, to provide adequate pain relief. The primary efficacy endpoint of the trial is the summed pain intensity difference over 48 hours, SPID48, starting on Post Op Day 1. Additional efficacy endpoints include use of opioid rescue medication and opioid related side effects, and Patient Global Assessment (PGA) of pain control. Bunionectomy surgery generally involves an incision in the top or side of the big toe joint and the removal or realignment of soft tissue and bone. This is done to relieve pain and restore normal alignment to the joint. Bunionectomy surgery typically results in intense post-operative pain. In the past, drugs that have demonstrated analgesic effectiveness following bunionectomy surgery have frequently translated that analgesic success into other post-operative procedures that result in moderate to severe, acute pain. Further Information Provided from REC-13-012 Day 0 Post Operative Pain Trial: On September 4, 2014, Recro announced findings from a prespecified interim analysis of its trial REC-13-012, which analyzed the first half of patients enrolled in the trial. The trial was a double-blind, placebo-controlled study of intranasal dexmedetomidine, Dex-IN, in the treatment of acute post-operative pain following bunionectomy surgery on Post Op Day 0. While analgesia and a reduction in opioid use were observed in a subset of patients, the Company elected to discontinue the study as it was not expected to reach statistical significance. The final analysis, which included 23 additional patients who were enrolled after the cutoff for the prespecified interim analysis (total of 95 treated patients /85 evaluable for SPID48), did not change the previously reported conclusion that the trial was not expected to reach statistical significance. Of the 23 additional patients, 8 patients had pain intensity scores of 6 or below. With the addition of these 8 patients (3 in placebo, 3 in 50 mcg and 2 in 35 mcg), there was a notable reduction in effect size and in the differences between treatment groups in opioid consumption. Effect size is a product of combined variability and of the magnitude of difference between treatment groups. The Company believes these changes are largely attributable to high variability frequently observed in pain studies, where a small sample size increase can notably affect efficacy outcomes. In this study, Dex-IN was well tolerated with noserious adverse events reported. Four patients (three in the 50 mcg Dex-IN treatment group and one in the 35 mcg Dex-IN treatment group) discontinued due to symptomatic hypotension and one subject (35 mcg Dex-IN) due to fever. Additionally, one subject discontinued placebo due to nausea and vomiting. No other adverse events of symptomatic hypotension were seen in the 95 patients treated. Asymptomatic decreases in blood pressure were seen throughout the study, including 10 Dex-IN patients (six in the 50 mcg Dex--IN treatment group) that had an adverse event of "BP decreased." In addition, one patient in the Dex-IN 50 mcg treatment group and two patients in the placebo treatment group had a heart rate of 50 bpm or below along with a notable change from baseline heart rate. Lastly, no clinically significant changes were seen in electrocardiograms in any treatment group, and there were no clinically significant changes in clinical laboratory studies.

Recro Pharma, Inc. Provides Clinical Strategy Update of Interim Analysis for Phase IIb Clinical Trial of Dex-In

Recro Pharma, Inc. announced a clinical strategy update following findings from a prespecified interim analysis conducted on the initial half of patients who completed enrollment in the Company's REC-13-012 trial. The trial is a double blind, placebo-controlled study of intranasal dexmedetomidine, Dex-IN, in the treatment of acute post-operative pain following bunionectomy surgery on Post Op Day 0. While analgesia and a reduction in opioid use were observed in a subset of patients, the study is not expected to reach statistical significance in its current design. As a result, the company plans to close this study and launch a revised study starting in fourth quarter of 2014. The company will evaluate Dex-IN 50 mcg versus placebo in management of post-op pain starting Post Op Day 1 after bunionectomy surgery. Note that there were no serious adverse events observed in the REC-13-012 trial. The interim analysis was based on the primary endpoint, SPID48 (summed pain intensity difference over 48 hours). This preplanned interim analysis was designed to allow for possible sample size adjustment. The results of the interim analysis (n=68, approximately 22 patients per group) revealed that the efficacy of Dex-IN as a stand alone drug was not sufficient to manage severe pain in bunionectomy on post operative day zero, Post Op Day 0. As a result, increased sample size is unlikely to be an effective modification of the trial. In the interim analysis, the company observed in patients with baseline pain intensity scores of <= 6 (N=34) that pain was more effectively managed on Post Op Day 0, as seen in the separation of scores between Dex-IN 50 mcg and Placebo. In addition, based on an understanding of the trajectory of pain, it is recognized that pain on Post Op Day 0 is generally escalating, while pain on Post Op Day 1, or the day after surgery, is generally stable or declining. Based on the input from the company's advisors, the results of the interim analysis and subset analyses, the information suggests that a post-operative pain management study in patients who initiate study treatment on Post Op Day 1 would be more effective than the current study design. The company expects such a study would enroll between 150 and 200 subjects, and is targeting initiation in fourth quarter of 2014, with top line results estimated to be available mid-year 2015.


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