Zogenix and Purdue Pharma said today they exchanged waivers of regulatory exclusivity applicable to their respective extended-release hydrocodone products, in a deal that will generate $10 million and may generate royalties for Zogenix.
The waivers apply to current or pending NDAs, as well as successor products – including those with abuse-deterrent properties and associated labeling claims, Zogenix said.
Purdue Pharma agreed to pay Zogenix $10 million in two installments – half within 15 days, the other half due July 1, 2015. In return, Zogenix said it could be eligible for royalties on future net sales of Purdue’s once-daily hydrocodone treatment “if certain sales conditions are met.”
“The non-dilutive capital from this agreement provides us with additional funds to invest in our recently expanded development pipeline,” Zogenix CEO Roger Hawley said in a statement.
Zogenix hopes to expand that pipeline further with a pending supplemental NDA, submitted earlier this month, for a version of extended-release Zohydro™ ER that includes abuse-deterrent features – as well as a planned NDA of the company’s next ER hydrocodone product with abuse-deterrent technology developed by Altus Formulations.
“We anticipate potential approval of the sNDA for Zohydro ER in the first quarter of 2015 and remain on track with the Altus formulation,” Hawley added. He did not say when the company expected to submit its NDA.
The announcement was made on the first day of a two-day public meeting between agency officials and representatives of drug developers with a stake in developing pain treatments. FDA says the meeting, will discuss the agency’s draft guidance on abuse-deterrent medications, released last year, and the broader issues of development, assessment, and regulation of abuse-deterrent formulations of opioid drugs.
In a Federal Register notice publicizing the meeting, the FDA insisted it will not require abuse-resistant features for opioid drugs, as sought by advocates and state officials alarmed by the increase in pain-drug abuse in recent years.
“Although FDA has received requests to require all opioid medications, or some subset of them, to be formulated with abuse-deterrent technologies, we have said that a class-wide requirement is not feasible or in the interests of public health at this time,” the agency stated. “This field is still in its early stages. Both the technologies involved and the clinical, epidemiological, and statistical methods for evaluating those technologies are new and rapidly evolving.”
Zogenix and the FDA have endured criticism because of the agency’s approval in October 2013 of the company’s Zohydro ER without requiring abuse-deterrent properties. Such properties were insisted upon by the agency for Purdue Pharma’s OxyContin (oxycodone) – but not for generic versions of oxymorphone product Opana ER (which like OxyContin was also reintroduced with abuse deterrence), as requested by its maker Endo Pharmaceuticals.
In September, 15 anti-addiction advocacy groups called for the Obama administration to fire FDA Commssioner Margaret Hamburg, M.D., accusing the agency of helping stoke a national epidemic of prescription painkiller abuse through the Zohydro approval: “We are especially frustrated by the FDA's continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” the groups wrote in a letter to U.S. Secretary of Health and Human Services Sylvia Burwell.
One of the advocacy groups, Physicians for Responsible Opioid Prescribing, petitioned the FDA for measures aimed at drastically curbing opioid use. That petition was rejected by the agency.
Purdue Pharma faces a civil lawsuit in Kentucky, which has accused the company of contributing toward opioid addiction in the state through its actions.
Kentucky filed the suit after rejecting $500,000 from the settlement of a federal suit against the company in 2007: “I want to hold them accountable in eastern Kentucky for what they did,” Kentucky Attorney General Jack Conway told Bloomberg News. The company has denied any wrongdoing, warned that the suit lawsuit could result in a $1 billion judgment against it, and cites its commitment over more than a decade toward curbing prescription-drug abuse.
This story has been corrected from an earlier version, which mistakenly said Zogenix is paying Purdue $10 million. GEN regrets the error.