Today, 9:04 AM
- Insys Therapeutics (NASDAQ:INSY) is ahead 9% premarket on increased volume in response to its announcement of successful results in its Phase 3 study assessing Buprenorphine Sublingual Spray for the treatment of moderate-to-severe postoperative pain in patients undergoing bunionectomy, a procedure that requires an incision on the top or side of the big toe joint.
- The primary endpoint was the summed pain intensity difference over 48 hours. The three dosages of Buprenorphine evaluated (0.5 mg 3x/day, 0.25 mg 3x/day, 0.125 mg 3x/day) were all statistically significantly better than placebo with the highest dose showing the largest reduction (expected for a pain medication).
- The company plans to discuss the results with the FDA by year end as well as the steps required to file a New Drug Application (NDA).
- Update: Slingshot Insights has a proposed expert interview to better understand these results as well as Recro Pharma's (NASDAQ:REPH) late-stage data on IV meloxicam. Astute investors will want to participate.
Wed, Aug. 17, 7:05 AM| Wed, Aug. 17, 7:05 AM
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- Ultra-thinly traded nano cap Recro Pharma (REPH +37%) heads north on a 7x surge in volume, albeit on turnover of only 105K shares, in response to its announcement of positive results from a 201-subject Phase 3 clinical trial assessing intravenous (IV) meloxicam for the treatment of acute postoperative pain in patients following bunionectomy surgery, a painful procedure that requires an incision in the top or side of the big toe joint.
- The study met its primary endpoint of showing a statistically valid reduction in pain intensity over 48 hours compared to placebo (p=0.0034). Participants were randomized 1:1 to receive either a postoperative regimen of IV meloxicam (30 mg bolus injection over 15-30 seconds) or placebo once every 24 hours up to three times.
- IV meloxicam was well tolerated with non serious adverse events or bleeding events reported.
- The company intends to submit additional data from the study for presentation at a future scientific conference or for publication.
- A second Phase 3 evaluating IV meloxicam in abdominoplasty surgery is ongoing. Top-line results should be available in Q4. If all goes well, a New Drug Application (NDA) will be submitted to the FDA in mid-2017.
- Meloxicam is an anti-inflammatory and analgesic agent called a COX-2 inhibitor. It has been marketed since the 1990s in an oral formulation by Boehringer Ingelheim. Recro acquired the rights to the intravenous/intramuscular formulation from Alkermes in April 2015.
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Jul. 17, 2015, 9:22 AM
Jul. 17, 2015, 8:15 AM
- A Phase 2 clinical trial assessing Recro Pharma's (NASDAQ:REPH) lead product candidate, Dex-IN, for the treatment of acute pain in adult patients undergoing bunionectomy surgery met its primary endpoint significant pain relief over 48 hours compared to placebo.
- The company intends to meet with the FDA to discuss the results and finalize the parameters of a pivotal Phase 3 trial.
- Dex-IN, an intranasal formulation of the sedative dexmedetomidine, is being evaluated for the non-opioid treatment of acute post-operative pain following bunionectomy (bunion removal) surgery, a very painful procedure which requires an incision in the top or side of the big toe joint.
- Shares are up 13% premarket on increased volume.
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Apr. 13, 2015, 11:02 AM
- Thinly-traded micro cap Recro Pharma (REPH +23.1%) heads north on a 3x surge in volume, albeit on turnover of only 300K shares. This morning the company announced the completion of its acquisition of assets from Alkermes plc, including the rights to the NDAID meloxicam, a contract manufacturing facility, royalty, and a formulation business.
- Under the terms of the agreement, Recro paid Alkermes $50M upfront, up to $120M in milestones and royalties on meloxicam sales. Recro adds over $70M to its top line with the deal.
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Recro Pharma, Inc. is a clinical stage specialty pharmaceutical company, whcih focused on products for hospitals and ambulatory care settings. The company is developing non-opioid products for treatment of serious acute pain. It offers drug solutions for cancer, musculoskeletal disorders and... More
Industry: Drug Manufacturers - Other
Country: United States