Texas-based Pain Therapeutics is urging the FDA to reconsider the Complete Response Letter it issued in August for the company’s opioid-treatment, Remoxy. Representatives from Pain Therapeutics will meet with the FDA on Jan. 31. 2019 to discuss the request, the company announced late Monday.
Texas-based Pain Therapeutics is urging the U.S. Food and Drug Administration (FDA) to reconsider the Complete Response Letter it issued in August for the company’s opioid-treatment, Remoxy.
Representatives from Pain Therapeutics will meet with the FDA on Jan. 31. 2019 to discuss the request, the company announced late Monday. Pain Therapeutics’ Remoxy is the proposed trade name for the company’s gel capsule formulation of oxycodone that Pain Therapeutics has billed as an “abuse-deterrent” medication. The company said there are physical and chemical properties in the twice-daily medication that are intended to deter abuse, compared to marketed extended-release oxycodone products.
In its announcement Monday, Pain Therapeutics outlined a number of areas where it disagreed with the FDA. The company said Remoxy has properties that deter against abuse, including injection abuse. The company also said that “excipients in Remoxy may pose a lower risk of health problems and possess a higher margin of safety compared to marketed extended-release oxycodone products.” Based on those reasons, as well as others, the company pushed for the meeting with the FDA to argue its case.
Remoxy has had a troubled history with the FDA. In 2008 the drug was rejected by the regulatory agency. After a series of deals surrounding Remoxy, the drug was resubmitted to the FDA in 2010 and was again rejected. The second time, pharma giant Pfizer was attached to the drug through a licensing deal. Pfizer said it intended to address the issues outlined in the CRL, but then opted to abandon it and give the rights back to Pain Therapeutics, BioSpace reported earlier. Two years ago the FDA kicked Remoxy back to Pain Therapeutics over concerns of potential abuse. That led to the latest request for regulatory approval, which was again rejected by the FDA.
In June an advisory committee overwhelmingly voted against the approval of Remoxy. The committee argued that the benefits of the medication did not outweigh the safety issues. The FDA followed suit in August with the latest CRL. Remi Barbier, the president and chief executive officer of Pain Therapeutics, was somewhat beside himself after the latest rejection. At the time, he called the FDA’s CRL a “bizarre conclusion to reach” due to the fact that the company had “an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin.” He added that because the country is in the midst of the opioid crisis, he believes that “Remoxy received an ideological judgment call that is vague in nature but conclusive in its damaging effects.”
On Monday, Barbier said that while the opioid crisis continues to rage, there are still deficiencies in many opioid medications that remain on the market.
“It’s a matter of national interest to address these deficiencies head-on, even if it means taking certain opioid drugs off the market. We don’t need regulatory runarounds. We need comprehensive and humanitarian solutions to the opioid crisis, including taking steps to stop drug abuse, curb unneeded opioid prescriptions, and reduce the risk of opioid use disorder in pain patients,” Barbier said in a statement.
