FDA Gives ‘Priority Review’ to New Hydrocodone Painkiller
The race to be the first drug maker to get approval for a hydrocodone painkiller with an abuse-deterrent formula continues to heat up.
Purdue Pharma says the Food and Drug Administration has given a priority review designation to the company’s hydrocodone bitartrate tablet, which is designed to make it harder for drug abusers to crush or liquefy for snorting or injecting. The FDA gives priority review to new drugs if they offer “significant improvements” in safety and effectiveness compared to existing medications.
Purdue filed a new drug application for its hydrocodone painkiller in April and expects the FDA to make a decision in October.
That is the same month San Diego based Zogenix (NASDAQ: ZGNX) plans to file a new drug application for an abuse deterrent formulation of Zohydro ER, the controversial hydrocodone painkiller the company introduced without any tamper resistant properties.
In addition to Purdue and Zogenix, Pfizer (NYSE: PFE) and Teva Pharmaceuticals (NYSE: TEVA) are also developing “pure” hydrocodone painkillers with abuse deterrent properties.
Until the introduction of Zohydro, the only hydrocodone products on the market were combined with acetaminophen, which at high doses can cause liver damage. Hydrocodone combination drugs such as Vicodin, Lortab and Lorcet are the most commonly prescribed and abused painkillers in the U.S. with over 130 million prescriptions annually.
“It is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualized care,” said Todd Baumgartner, MD, Vice President of Regulatory Affairs and Chief Medical Officer at Purdue Pharma. “If approved by the FDA, this product will be a valuable therapy for treating chronic pain, and it is also designed to deter misuse and abuse by various routes of administration.”
Zogenix is developing two different abuse deterrent formulations for Zohydro ER. One would make Zohydro extended release capsules harder to crush or liquefy. The company hopes that formulation will be approved in early 2015.
Zogenix is also developing a Zohydro tablet in collaboration with Altus Formulation. The tablet would be extremely hard to make it difficult to crush and would also contain other properties to discourage drug abusers from injecting it. A new drug application for a Zohydro tablet isn’t expected until the first half of 2016.
We believe we have two strong technology options to deter misuse and abuse without affecting the established safety and efficacy profile of Zohydro ER, and look forward to submitting our data to the FDA with the goal of bringing these new options to patients, said Stephen Farr, President of Zogenix. We also continue to take part in comprehensive and collaborative efforts with prescribers, pharmacists and government officials to help ensure appropriate patients have access to the medications that will best support the management of their severe chronic pain.
A wave of controversy has surrounded Zohydro since its introduction in March. Some politicians and addiction treatment experts have claimed the painkiller will fuel a new wave of narcotic addiction because it does not come in an abuse-deterrent formula.
Massachusetts Gov. Deval Patrick tried to ban the prescribing of Zohydro in his state, a move that was blocked by a federal judge who ruled the governor was interfering with the authority of the FDA to regulate prescription drugs.
After his emergency order was ruled unconstitutional, Gov. Patrick then announced new restrictions on Zohydro that require doctors to evaluate a patient’s substance abuse history, provide a letter of medical necessity to pharmacies, and sign a pain management treatment agreement with all patients who are prescribed the drug.
Zogenix filed a federal lawsuit saying the new regulations are unconstitutional and impose “draconian” restrictions that “amount to an effective ban of the drug.” A judge has yet to rule on the case.