Purdue gets FDA nod for abuse-deterrent painkiller

Purdue Pharma has expanded its portfolio of opioid analgesic drugs following FDA approval of Hysingla ER, a once-daily product designed to resist abuse.

Faced with an epidemic of prescription painkiller abuse, the FDA drew up new guidance last year to try to encourage the development of safer forms of these drugs and the agency notes that Hysingla ER (hydrocodone bitartrate) meets those objectives.

The drug is difficult to crush, break or dissolve so resists misuse attempts by chewing, snorting and injection, said the agency in a statement, although it notes abuse by these routes may still be possible.

According to figures from the Centers for Disease Control and Prevention (CDC), every day in the US 105 people die as a result of drug overdose with opioid analgesics killing more than 16,600 people in 2010, more than four times the number of people killed by these drugs in 1999.

At the same time, $9bn-worth of opioid analgesics were prescribed in 2013, more than double the amount 10 years previously, according to IMS Health.

Hysingla ER is designed for 24-hour pain relief, and not for use on demand, said the FDA. Purdue already sells an abuse-deterrent product version of its OxyContin (oxycodone) product, and earlier this year got approval in the US for another around-the-clock opioid painkiller, Targiniq ER, which combines oxycodone with naloxone to help limit the effects of opioid overdose.

The new product will compete in the marketplace against products such as Zogenix' 12-hour Zohydro ER (hydrocodone), another long-acting opioid analgesic which was approved by the FDA last year but has no abuse-deterrent features.

Zogenix filed for approval of a line extension based on an abuse-resistant formulation in September, and recently signed a $10m exclusivity waiver agreement with Purdue that will allow the latter to launch its extended-release hydrocodone product without triggering patent infringement litigation. The reformulated Zohydro ER could be on the market as early as the first quarter of 2015.

In a blog post, FDA's director of the Center for Drug Evaluation and Research Commissioner (CDER), Janet Woodcock, said there are important differences between the two products.

"Hysingla ER has approved abuse-deterrent labelling, while Zohydro ER does not. Also, Zohydro ER is taken every 12 hours, and so comes in lower dosage strengths than Hysingla ER, which is taken every 24 hours," she said.

"FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER."

Prescription opioids with abuse-deterrent properties will not completely fix the prescription opioid abuse problem, but they can be part of a comprehensive approach to combat the epidemic, added Woodcock.