Recro Pharma, Inc. (NASDAQ: REPH)
Shares of Recro Pharma lost more than half of their value on Thursday morning after the FDA dismissed a non-opioid pain shot manufactured by the company. The regulator said the analgesic effect offered by IV meloxicam failed to satisfy its requirements.
The Pennsylvania-based pharmaceutical company said the regulator’s Office of DRUG Evaluation II has issued it a Complete Response Letter (CRL) in regards to IV meloxicam.
The letter stated that even though IV meloxicam had shown statistically considerable results in its pivotal phase-3 trials primary endpoints, the regulator would not to approve the application as it is now.
The letter pointed out that data from selective secondary endpoints and ad hoc analyses endpoints showed that the pain-relieving effect did not match the expectations of the regulator. It also questioned the chemistry, manufacturing, as well as the controls that were applied in making the drug.
The move by the FDA deals Recro Pharma a huge blow considering IV meloxicam would have been its first drug. The company presently makes money from manufacturing and other related services offered by pharmaceuticals.
For the period ended March 31, the company had $51.3M in cash. Recro bought IV meloxicam from Alkermes PLC three years ago, and now plans to meet with the regulator to know its fate.
At the time of writing, shares of the company were exchanging hands at $5.59 after losing $6.83 (54.99%). This is a huge hit to the company and investors which has also pushed the stock into penny stock land, which is usually below $5.00.
Recro Pharma CEO Comments
Recro Pharma President and Chief Executive Officer Gerri Henwood issued a statement saying: “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.”
Recro Pharma, Inc. Company Profile
Recro Pharma is a revenue-making specialty pharmaceutical firm that engages in the development of non-opioid products. The products are primarily targeted at the U.S. market to treat acute pain.
Its products include injectable IV meloxicam for post-operative pain treatment. The company also develops a dexmedetomidine intranasal formulation known as Dex-IN, which is used for treating peri-procedural pain and post-operative pain.
In addition, the company offers manufacturing and contract development services. On top of that, Recro has a partnership with Orion Corp for the creation and marketing of Dexmedetomidine.
It focuses on availing its product line to hospitals and other related markets. Recro was founded in 2007 and its head offices are located in Malvern, PA. At the time of its establishment, the company was called Recro Pharma I, Inc. It changed to its present in August 2008.
Some of its competitors include Adare Pharmaceuticals, Johnson & Johnson, Pacira Pharmaceuticals, Purdue Pharma, L.P., Patheon Holdings, Depomed, Inc., Endo Pharmaceuticals, Mayne Pharma Group Ltd., Mallinckrodt PLC, and Catalent, Inc. –Reuters