Recro Pharma (REPH) Announces CRL from FDA for IV meloxicam NDA
- S&P 500 ends slightly lower after jobs report
- U.S. job juggernaut rolled on in November; nonfarm payrolls up 263,000
- We are selling risk rallies - Bank of America's Hartnett
- United Airlines (UAL) nearing deal to order dozens of Boeing 787 Dreamliners - WSJ
- Meta Platforms says metaverse could contribute over $3 trillion to global GDP by 2031
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
Recro Pharma, Inc. (Nasdaq: REPH) announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) Office of Drug Evaluation II regarding the New Drug Application (NDA) for IV meloxicam.
The CRL stated that although the outcome of the pivotal phase III trials demonstrated statistically significant outcomes on the primary endpoints, the FDA is unable to approve the application in its current form. The CRL states that data from ad hoc analyses and selective secondary endpoints suggest that the analgesic effect does not meet the expectations of the FDA. In addition, the CRL raised CMC related questions on extractable and leachable data provided in the NDA.
“We are extremely disappointed for patients and providers who are looking for a non-opioid alternative for relief of pain. We stand behind the body of evidence included in our NDA and are committed to further discussions with FDA in order to bring this important medicine to patients. We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and look forward to working with the Agency to find solutions that can contribute to solving the current opioid public healthcare problem,” said Gerri Henwood, President and Chief Executive Officer of Recro.
Conference Call and Webcast
Recro Pharma management will be hosting a conference call and webcast today beginning at 8:00 a.m. ET. To access the conference call, please dial (844) 243-4691 (local) or (225) 283-0379 (international) at least 10 minutes prior to the start time and refer to conference ID 9385399. A webcast will be available in the investor relations section of the Company's website, www.recropharma.com. A live audio webcast of the call will be available under "Events" in the Investor section of the Company's website, https://ir.recropharma.com/events. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 60 days.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Rigel Pharma (RIGL) Announces U.S. FDA Approval of REZLIDHIA for Treatment of Adult Patients with R/R Acute Myeloid Leukemia with Susceptible IDH1 Mutation
- Vanda Pharmaceuticals (VNDA) Reports Results in Phase II Clinical Study of VQW-765 in the Treatment of Acute Performance Anxiety
- Citius Pharmaceuticals (CTXR) Announces FDA Acceptance of BLA of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News, Hot FDA News, Trading Halts
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!