FDA, Setbacks

Mallinckrodt’s woes persist as reformulated opioid painkiller fails to pass FDA muster

The FDA’s reluctance with prescription painkillers at a time the United States is swept by a tsunami of opioid abuse, overdose and addiction was on full display on Wednesday, when the regulator rejected Mallinckrodt’s $MNK abuse-deterrent opioid painkiller, soliciting more data from the UK drugmaker.

The drug under scrutiny was a tweaked version of Roxicodone, an immediate-release formulation of the commonly abused opioid oxycodone that was approved by the FDA in 2000. This reformulation was designed to deter abuse via snorting or injecting. In its CRL, the agency “provided guidance regarding areas of further evaluation necessary to resubmit the NDA for further review,” Mallinckrodt said.

Shares of the Staines-upon-Thames-based company, which said it would spin off its specialty business last week, were down about 9% pre-market. The announcement follows another setback: one of two late-stage drugs Mallinckrodt won as part of its $1.2 billion acquisition of Sucampo failed a pivotal study in November.

The CRL for the painkiller does not come as a complete surprise. In a review last month, FDA staff pointed out that the agency had not made any definitive conclusions regarding whether the drug could be manipulated for intravenous abuse, as Mallinckrodt had not yet submitted data from several key studies as part of its NDA. A panel of independent experts reviewing the drug a few days later concurred, suggesting the drug be labeled as an abuse deterrent only via the nasal route.

This could culminate in a similar situation to that of Endo’s $ENDP Opana, which was withdrawn from the market last year at the behest of the FDA, after post-market data showed the reformulated opioid painkiller was being abused intravenously at a higher rate, even as rates of nasal abuse fell.

But Mallinckrodt is planning to plough ahead. The company intends to request a meeting in the coming weeks with the regulator to discuss its next steps, it said on Wednesday.

On average, opioid overdoses kill 115 Americans per day, and the economic burden of prescription opioid misuse alone is a hefty $78.5 billion each year, including the healthcare costs, lost productivity, and criminal justice involvement, according to the CDC. As the number of opioid-related deaths mount, the FDA has largely changed its tune on the oft’ misused class of drugs by amending its prescribing recommendations,tracking the number of prescriptions, tightening scrutiny and requiring manufacturers to develop abuse-deterrent formulations.

However, the agency is not quite imposing a blanket ban on all things opioid. Last month, it approved AcelRx Pharmaceuticals $ACRX painkiller Dsuvia, a drug 10-times more potent than fentanyl, which in turn is a synthetic opioid pain reliever that is 50 to 100 times more potent than morphine. The controversial approval was sanctioned despite heightening concern and fiery criticism (from a host of critics including a handful of US senators) on the grounds that the drug — which was developed in collaboration with the Department of Defense — is a sublingual formulation, making it ideal for military use, noted FDA Commissioner Scott Gottlieb.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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