On May 23, 2018, we published revised versions of our Privacy Policy and User Agreements. Please read these updated terms and take some time to understand them. Your use of our services is subject to these revised terms.
Yes, I Agree.

Recro Pharma, Inc. (REPH) Says No to Opioids for Post-Operative Pain Control with IV Meloxicam

An announcement earlier this week from revenue-generating specialty pharmaceutical company Recro Pharma, Inc. (NASDAQ: REPH) is good news for those suffering from pain after major surgery. From its headquarters in Malvern, Pennsylvania, the company announced positive results from a phase III clinical trial evaluating intravenous (IV) Meloxicam for the treatment of acute post-operative pain.

In this trial, the second of two phase III trials, IV Meloxicam achieved the primary endpoint of a statistically significant differential in Summed Pain Intensity Difference over the first 24 hours (SPID-24) in patients who had undergone abdominoplasty surgery, as compared to placebo. With the positive data from this study, the company believes this completes the efficacy program for IV Meloxicam and opens the way for a New Drug Application (NDA).

A report from Aegis Capital (http://dtn.fm/Kx7Za), released earlier this month when it initiated coverage on Recro Pharma, shows why this is a big deal. Aegis estimates the size of the U.S. post-operative pain market at around $5.9 billion. At present, many of the analgesics employed, such as morphine, codeine, and hydrocodone, are opioids. But such powerful anodynes are notoriously addictive and their use is often subverted from pain relief. According to the Centers for Disease Control (CDC), 29,000 Americans die every year from opioid-related overdoses.

Consequently, there is growing demand for less addictive pain medications, particularly in the post-op environment, where conventional pain management drugs such as morphine are still commonly used. In addition to being less addictive than morphine, IV Meloxicam can be delivered as a 15-second infusion and has been shown to have fast onset of action in clinical trials. As a result of these factors, Aegis expects peak year revenue for IV Meloxicam to be in the range of $150-200 million.

This trial focused on testing the efficacy of IV Meloxicam in combating pain following abdominoplasty surgery, a complicated procedure that generally involves the removal of excess fat and skin and may include the restoration of weakened or separated muscles from the abdominal area. The American Society for Aesthetic Plastic Surgery reports that abdominoplasty is among the top five most common cosmetic surgeries in the U.S., with more than 164,000 performed in 2014. It is a procedure that, typically, results in intense postoperative pain.

In July, Recro announced positive top-line data from the IV Meloxicam (30 mg dose per 24 hours) in bunionectomy phase III trial. This first phase III trial measured its primary endpoint in terms of Summed Pain Intensity Difference over 48 hours (SPID-48) and showed a statistically significant reduction in SPID-48 versus placebo. It also achieved statistical significance across 15 of 19 secondary endpoints.

With the successful completion of these two phase III trials, an NDA is expected to be filed in summer 2017, followed by potential FDA approval in mid-summer 2018.

Recro Pharma is a clinical development-stage pharmaceutical company geared toward the development of non-opioid treatments for the management of acute pain in hospital and ambulatory care (outpatient) settings. The company currently earns revenue from a contract manufacturing, royalty and formulation business in Gainesville, Georgia, acquired in April 2015 from Alkermes, the Irish drug maker. Its lead product candidate, IV Meloxicam, is a cyclo-oxygenase 2 (COX-2) inhibitor, exclusive worldwide rights to which were acquired as part of the 2015 Alkermes deal.

Aegis originally put a price target on Recro Pharma stock, currently trading on the NASDAQ at around $9.00 under the symbol REPH, of $21.00. This was based on a 70% probability that the abdominoplasty phase III trial would be successful. With that study yielding such decidedly positive results, the price target was raised to $25.00 in an updated report (http://dtn.fm/Lvu6Y).

For more information, please visit www.RecroPharma.com

Archives

Select A Month
  • October 2024
  • September 2024
  • August 2024
  • July 2024
  • June 2024
  • May 2024
  • April 2024
  • March 2024
  • February 2024
  • January 2024
  • December 2023
  • November 2023
  • October 2023
  • September 2023
  • August 2023
  • July 2023
  • June 2023
  • May 2023
  • April 2023
  • March 2023
  • February 2023
  • January 2023
  • December 2022
  • November 2022
  • October 2022
  • September 2022
  • August 2022
  • July 2022
  • June 2022
  • May 2022
  • April 2022
  • March 2022
  • February 2022
  • January 2022
  • December 2021
  • November 2021
  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • June 2021
  • May 2021
  • April 2021
  • March 2021
  • February 2021
  • January 2021
  • December 2020
  • November 2020
  • October 2020
  • September 2020
  • August 2020
  • July 2020
  • June 2020
  • May 2020
  • April 2020
  • March 2020
  • February 2020
  • January 2020
  • December 2019
  • November 2019
  • October 2019
  • September 2019
  • August 2019
  • July 2019
  • June 2019
  • May 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • September 2018
  • August 2018
  • July 2018
  • June 2018
  • May 2018
  • April 2018
  • March 2018
  • February 2018
  • January 2018
  • December 2017
  • November 2017
  • October 2017
  • September 2017
  • August 2017
  • July 2017
  • June 2017
  • May 2017
  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • September 2016
  • August 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013
  • May 2013
  • April 2013
  • March 2013
  • February 2013
  • January 2013
  • December 2012
  • November 2012
  • October 2012
  • September 2012
  • August 2012
  • July 2012
  • June 2012
  • May 2012
  • April 2012
  • March 2012
  • February 2012
  • January 2012
  • December 2011
  • November 2011
  • October 2011
  • September 2011
  • August 2011
  • July 2011
  • June 2011
  • May 2011
  • April 2011
  • March 2011
  • February 2011
  • January 2011
  • December 2010
  • November 2010
  • October 2010
  • September 2010
  • August 2010
  • July 2010
  • June 2010
  • May 2010
  • April 2010
  • March 2010
  • February 2010
  • January 2010
  • December 2009
  • November 2009
  • October 2009
  • September 2009
  • August 2009
  • July 2009
  • June 2009
  • May 2009
  • April 2009
  • March 2009
  • February 2009
  • January 2009
  • December 2008
  • November 2008
  • October 2008
  • September 2008
  • August 2008
  • July 2008
  • June 2008
  • May 2008
  • April 2008
  • March 2008
  • February 2008
  • January 2008
  • December 2007
  • November 2007
  • October 2007
  • September 2007
  • August 2007
  • July 2007
  • June 2007
  • May 2007
  • April 2007
  • March 2007
  • February 2007
  • January 2007
  • December 2006
  • November 2006
  • October 2006
  • September 2006
  • August 2006
  • July 2006
  • June 2006
  • May 2006
  • April 2006
  • March 2006
  • January 2006
  • December 2005
  • October 2005
  • September 2005
  • Market Basics

    New to the micro-cap markets?Get answers to your questions about investing in Small-Cap / Micro-Cap Stocks and learn how to protect yourself.

    The Basics

    Newsletter Publishers

    Have an up and coming newsletter and want to be included in our coverage list? Looking to get more coverage and grow subscriptions? Register for coverage.

    Register

    Public Companies

    Are you a Small-Cap / Micro-Cap company looking for coverage? We'd love to hear from you. Fill out our quick contact form or send us a text.

    Get Covered