FDA sends response letter requesting studies to assess abuse-deterrent properties of oxycodone extended release.
The US Food and Drug Administration (FDA) rejected Intellipharmaceutics’ extended-release abuse-deterrent oxycodone hydrochloride painkiller (Rexista).
The company received a Complete Response Letter (CRL) from the FDA requesting that Intellipharmaceutics complete relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration. The FDA is in need of more evidence proving the treatment has characteristics that make it harder to abuse.
An alternate proposed proprietary name for Oxycodone ER has also been requested. The company had been using the brand name Rexista, however is now calling it Oxycodone ER until further notice.
The FDA also requested additional information related to the inclusion of the blue dye in Rexista’s formulation, determining it cannot be approved in its present form.
Intellipharmaceutics has been allowed 1 year to response to the CRL, and if necessary, can request additional time.
In February, the FDA accepted the filing for Intellipharmaceutics’ Rexista in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 22 to 1 in July, rejecting Rexista, citing safety concerns about the ability of the product to deter abuse, voting against abuse-deterrent labeling.
The committee also voted 23 to 0 on insufficient data for Rexista to support inclusion of language regarding abuse-deterrent properties in the product label for the intravenous route of administration.
Rexista is indicated for the management of pain severe enough to require daily, around the clock, long-term opioid treatment, for which alterative treatment options are inadequate. Long-acting opioids contain high doses of narcotics designed to be released over time and if crushed, snorted or injected, release their full dose all at once making them dangerous and valuable for addicts.
The FDA's decision comes as the US battles an opioid abuse crisis, which claimed more than 33,000 people in 2015, according to the US Centers for Disease Control and Prevention (CDC).
Arwen Podesta, Podesta Wellness LLC, Tulane Clinical Psychiatry faculty, told MD Magazine that it's important to understand what different drugs or medicines have done to individuals.
"If we know that someone is going to get kind of spun up, and get energy from using opioids, or if they've ever misused opioids recreationally even in college and they're very far out, then they're more likely to become addicted to their pain medications at this time.
The drug contains a blue dye that’s emitted if the tablet is manipulated and abused orally or via the intranasal route. It’s intended to present a significant barrier to tampering when manipulated by abusers, as well as dose dumping when inadvertently co-administered with alcohol.
In addition, when Rexista is crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a hydrogel, which is intended to prevent syringing, injecting and snorting.
Intellipharmaceutics International Inc. is currently involved in a class action law suit on behalf of a class of investors who purchased or acquired IntelliPharma securities, seeking to recover compensable damages caused by violations of the Securities Exchange Act of 1934.
Investors alleged Intellipharmaceutics made false and misleading claims about its abuse-deterrent opioid painkiller failing to disclose that the company did not conduct a human abuse liability study to support its New Drug Application (NDA), did not include abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of the drug by various pathways, did not submit sufficient data to support approval of the Rexista NDA, and company public statements were materially false and misleading at all relevant times.
The company informed investors it was certain Rexista prevented abuse, and the FDA said data proving so was not actually provided by the company.
While lab tests were conducted to evaluate the abuse potential of its formulation, the company had not conducted any human studies to prove its product works as intended.
Since Rexista is shown to be bioequivalent, and interchangeable with OxyContin in lab studies, the company believed conducting human studies prior to applying for approval was not imperative.
Safety studies on the blue dye were also not conducted, raising concerns about the ingredient’s potential toxicity and whether the bright color would attract addicts opposed to deterring them.
A press release was made available.