recro pharma inc (RAH) Key Developments
Recro Pharma, Inc. Announces Update on On-Going Phase II Clinical Trial of Dex-In for Treatment of Acute Pain on Day 1 Following Surgery
Apr 9 15
Recro Pharma, Inc. announced that it had completed the prespecified interim analysis conducted on the company's Phase II, double-blind REC-14-013 trial of Dex-IN in patients who initiate dosing of study medication on Post Op Day 1 following bunionectomy surgery. The purpose of the interim analysis was to allow for a sample size adjustment, if necessary, to maintain the ability to detect a difference in treatment effects between Dex-IN and placebo. The trial was expected to enroll approximately 200-250 patients. As a result of the interim analysis, the total enrollment for the trial was adjusted to approximately 170 patients. 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. Patients who meet the eligibility criteria are randomized to either a 50Âµg dose of Dex-IN or a placebo intranasal dose given every 6 hours. Following the beginning of treatment, patients remain under observation for 48 hours at study centers. Patients are followed for 7 days after the initial dose of study medication. There is 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, other pain parameters and opioid related side effects, as well as 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.
Recro Pharma, Inc. Reports Earnings Results for the Fourth Quarter of 2014
Mar 25 15
Recro Pharma, Inc. reported earnings results for the fourth quarter of 2014. For the period, the company reported a net loss applicable to common shareholders of $3.5 million, or $0.45 per share, compared with a net loss for fourth quarter of 2013 of $496,927, or $3.19 per share. The per-share comparison was skewed by a surge in the number of shares outstanding to 7.7 million from just 155,600. The wider loss came as the company's quarterly research-and-development expenses surged to $2.3 million from $61,896 in the prior-year period. It isn't yet generating revenue.
Alkermes plc, Recro Pharma, Inc. - M&A Call
Mar 9 15
Recro Pharma to acquire IV/IM Meloxicam and Gainesville, GA GMP Manufacturing facility and business unit from Alkermes
Recro Pharma, Inc. Presents at 17th Annual BIO CEO & Investor Conference, Feb-09-2015 11:00 AM
Dec 15 14
Recro Pharma, Inc. Presents at 17th Annual BIO CEO & Investor Conference, Feb-09-2015 11:00 AM. Venue: The Waldorf Astoria, New York, New York, United States. Speakers: Geraldine A. Henwood, Chief Executive Officer, President and Director.
Recro Pharma, Inc. Reports Unaudited Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014
Nov 10 14
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.