A manufacturing problem has led to an outage of the 20-mg strength version of the tamper resistant form of the opioid pain drug Zohydro until next year, but the drug company cautioned the issue could end up affecting other strengths as well.
Pernix Therapeutics Monday said that because of a supplier's manufacturing problem, it expected the 20-mg strength version of its pain drug, Zohydro ER with BeadTek, to be on backorder until at least the first quarter of 2018.
Pernix will continue to distribute the tamper resistant Zohydro ER in 10-mg, 15-mg, 30-mg, 40-mg and 50-mg strengths, it said. Most of those strength, Pernex explained, are consistent with the morphine milligram equivalents that are recommended in the recent Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain.
The continuing problem, Pernix said, is that as doctors switch patients that had been taking the 20-mg dose to the 10-mg, 15-mg and 30-mg strengths, the pharma “anticipates the temporary stockout to impact the overall Zohydro ER with BeadTek prescription volume.”
Pernix said it is evaluating the what the “scope of any potential impact” might be and would update the market when it has a handle on that. It also said it is working with its supplier to ensure the return of the 20-mg strength to the marketplace as soon as possible.
New Jersey's Pernix acquired the controversial all-hydrocodone painkiller from developer Zogenix in 2015 for $100 million in cash and up to $283.5 million in milestones. While the FDA had approved the tamper-resistant version of Zohydro, it wouldn’t allow Pernix to use abuse deterrence as a selling point until it submitted further data for a label update.