Recro Pharma is a revenue-generating, specialty pharmaceutical company focused on products for hospitals and ambulatory care settings that is currently developing non-opioid products for the treatment of acute pain. Our lead product candidate is a proprietary injectable form of meloxicam. Intravenous, (IV), meloxicam has successfully completed multiple Phase II clinical trials for the treatment of moderate to severe pain. We believe injectable meloxicam compares favourably to competitive therapies in extent of pain relief, onset of pain relief and duration of pain relief.
Our pipeline also includes Dex-IN, a proprietary intranasal formulation of dexmedetomidine (Dex), which successfully completed a Phase II clinical trial in post-operative pain. Based on feedback from the FDA regarding the benefit-risk profile of Dex-IN, we plan to pursue Dex-IN in peri-procedural pain. If approved, Dex-IN would also be the first approved peri-procedural pain drug in its class of drugs.
As our product candidates are non-addictive, non-opioid drugs, we believe our candidates would avoid many of the side effects associated with commonly prescribed opioid therapeutics, such as addiction, constipation and respiratory depression while maintaining meaningful analgesic effects. We believe our product candidates could provide an attractive alternative pain medication alternative to help avoid use of opioids for the more than 50 million surgical procedures that require post-operative pain medication.
We currently own and operate a 97,000 square foot, DEA-licensed manufacturing facility that makes five commercial products and receives royalties associated with the sales of these products.
Based upon statistics from the National Center for Health Statistics, it is estimated that there are over 100 million surgeries performed in the United States each year. Of these surgeries, we believe at least 50 million procedures, as referenced by the National Center for Health Statistics require post-operative pain medication. While opioids are generally considered the most effective treatment for post-operative pain, they raise serious concerns due to addiction, illicit use, respiratory depression and other side effects, including constipation, nausea, vomiting and intolerance. Due to their addictive potential, opioids are regulated as controlled substances and are listed on Schedule II and III by the DEA. As a result of these side effects, pain sufferers or their treating physicians, tend to limit their use of opioids, resulting in as many as 40% of post-operative patients reporting inadequate pain relief. This reduces the quality of life for individuals and creates an economic burden estimated to be at least $560 to $635 billion a year in medical costs and lost productivity.
According to a January 2016 article in the New England Journal of Medicine, overdose deaths from prescription painkillers (defined to mean opioid or narcotic pain relievers) has increased significantly over the past 14 years. It notes the following trends:
- Prescription painkiller overdoses killed 18,893 people in the United States in 2014;
- In 2014, about 10.3 million Americans (age 12 or older) reported nonmedical use of prescription painkillers in the past year; and
- Emergency department visits involved with misusing or abusing prescription opioid painkillers increased 153% between 2004 and 2011.
We believe that injectable Meloxicam offers an attractive alternative for pain relief without the risks associated with opioids. Accordingly, we believe that physicians and third-party payors, including Medicare and Medicaid, are highly interested in new non-opioid pain therapies that provide effective pain relief without the adverse issues associated with opioids.
Contact UsRecro Pharma, Inc.
1300 Gould Dr
Gainesville, GA 30504