- Before it can grant approval to a painkiller from Intellipharmaceutics International Inc., the Food and Drug Administration needs more evidence the treatment actually has characteristics that make it harder to abuse.
- In a recently issued complete response letter (CRL), the agency rejected Intellipharmaceutics' extended-release oxycodone hydrochloride and requested the company conduct pharmacokinetic and clinical abuse deterrent studies.
- Additionally, regulators want Intellipharmaceutics to come up with a new proprietary name for the drug, according to a Sept. 25 statement. The company had been using the brand name Rexista, but is now simply calling the program Oxycodone ER until further notice.
Painkiller abuse has hit epidemic levels in the U.S. over the past few years. The Centers for Disease Control and Prevention estimates that deaths from prescription opioid overdoses have quadrupled since 1999 — more than 15,000 people in the states died that way in 2015 alone. Those deaths are contributing to an overall increase in drug overdose deaths, which some reports claim now cost more lives than the Vietnam War.
As a result, federal regulators, state governments and congressional leaders have attempted to crack down on opioid manufacturing. The Drug Enforcement Agency just last month revealed it was considering instituting a 20% reduction in opioid painkiller production for 2018, with key targets being oxycodone, morphine, fentanyl and other schedule II opioid painkillers.
The FDA has also actively reshaped how it handles such drugs. Last year, it decided to require all products containing opioids and benzodiazepines to carry boxed warnings about the dangers of mixing the two drug classes. And this summer, the agency made an unusual move and asked Endo Pharmaceuticals Inc. to take its extended release oxymorphone, Opana ER, off the market — a request the company later complied with.
The backlash against opioid-based treatments has in large part been because of their highly addictive nature. With that in mind, many drugmakers in the pain space are investing in medicines that are more difficult to abuse. Purdue Pharma, for example, received FDA approval in 2014 for its abuse-deterrent drug Targiniq ER (naloxone/oxycodone). Nektar Therapeutics, too, has its own opioid-based painkiller, which had a positive late-stage readout earlier this year. Heron Therapeutics, meanwhile, is progressing its non-opioid analgesic into Phase 3 testing.
Conversely, Intellipharmaceutics' drug hasn't fared so well. Its rejection isn't very surprising given that a July meeting with the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee resulted in a nearly unanimous vote against approving Rexista and a completely unanimous vote that there wasn't enough data to say it was abuse-deterrent.
In spite of the setback, Intellipharmaceutics remains confident in its candidate.
"We are very encouraged by the FDA’s response as it clarifies our path forward for Oxycodone ER," Isa Odidi, the company's CEO, said in the Sept. 25 statement. "We had already planned the additional Category 2 and Category 3 studies the FDA has requested and we do not expect they will impact our anticipated commercialization timeline for Oxycodone ER."
Among the additional data the FDA is looking for is the role a blue dye plays in the Oxycodone ER formulation. Intellipharmaceutics said the dye helps with the abuse-deterrence.
"We will continue to work closely with the FDA to provide them with the additional information they requested, including data supporting the label claims related to Oxycodone ER’s abuse-deterrent properties," Odidi said. "We believe our Oxycodone ER product can play an important preventative role in the midst of a serious opioid abuse crisis particularly impacting North America."