Recro Pharma Halts Pain Drug Study Due To Fault In Trial Design; Stock Tanks
September 5, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Shares of Malvern, PA-based Recro Pharma , a clinical-stage pharmaceutical company, plunged 49% in pre-market trading on Friday after the company announced it was halting a trial of its lead product candidate Dex-IN. The company decided to stop the trial because it does not believe the study will “achieve statistical significance in its current design.” Recro Pharma emphasized that safety was not an issue, stating there were “no serious adverse events” in the participating patient population.
Dex-IN, an intranasal form of dexmedetomidine, was being tested as an analgesic, or pain-relief, drug for post-operative pain. Earlier, the drug passed a Phase Ib trial that demonstrated its proof of concept in providing effective pain relief. The recently halted study design involved administering Dex-IN “in a bunionectomy pain model starting on Post Op Day 0.”
Though the results of that trial were disappointing, they do suggest that administering Dex-IN on Post Op Day 1 could achieve efficacy to a statistically significant degree. Recro Pharma will launch a revised study starting in Q4 2014 to test Dex-IN on Post Op Day 1 and expects to enroll 150 to 200 patients in the double blind, placebo-controlled study.
“There remains a significant unmet medical need for opioid-sparing analgesics, a need which we continue to believe may be addressed with Dex-IN,” said Gerri Henwood, Recro Pharma's President and Chief Executive Officer.
At present, doctors prescribe primarily opioids for pain management—a class of drugs that includes hydrocodone and oxycodone, which are narcotic analgesics. Though these drugs effectively manage pain, they have serious side effects that include respiratory distress, constipation, and most seriously, addiction. The FDA makes clear the dangers of opioids on its information page about the drugs: “When [opioids are] prescribed by physicians to patients who should not receive them, or when used improperly or for recreational purposes, they can cause serious harm, including overdose and death."
Due to the serious side effects of opioid analgesics, and rising public opinion that we are in the midst of an opioid-addiction epidemic , the market is ripe for non-opioid analgesic drugs. Reco Pharma believes Dex-IN could be the solution. According to the company, “If approved, Dex-IN would be the first and only approved acute pain drug in its class of drugs.”
In March 2014, Recro Pharma went public, which netted the company $30 million to fund the Dex-IN trials. The shares sold for $8 in March. In pre-market trading on Friday, the share price had fallen to $2.80.