Drug maker Zogenix Inc. (NASDAQ: ZGNX) says its controversial new opioid painkiller Zohydro is now available in “select” pharmacies in the United States, a drug that some addiction treatment experts say could fuel a new wave of narcotic addiction and overdose deaths.
Company officials say their introduction of Zohydro will be “measured, conservative and cautious,” but they eventually plan to market the extended release painkiller to 15,000 physicians who specialize in pain management.
“We have been rather thoughtful, if you will, about focusing on making sure we get to prescribers as soon as we possibly can,” said Zogenix CEO Roger Hawley during a conference call with analysts on the company’s 2013 fourth quarter results.
“We’ve taken every measure we could think of that could impact successfully the introduction of this product, as well as minimize its potential for abuse and misuse.”
Zohydro is the first pure hydrocodone painkiller sold in the U.S. Company officials say it will not be marketed directly to consumers and free samples will also not be offered, a common practice when many new drugs are launched.
“We certainly recognize and understand the public health concerns regarding extended released opioid products and our responsibility as a manufacturer to balance patient access with the risk of misuse, abuse, and unintentional overdose of single entity hydrocodone,” said Zogenix President Stephen J. Farr.
The Food and Drug Administration approved Zohydro last October over the objections of its staff and advisory committee, which warned there was potential for Zohydro to be abused even more than currently available hydrocodone combination products.
Last month a coalition of addiction treatment experts, healthcare agencies, and individuals who have lost loved ones to drug overdoses urged the FDA to revoke its approval of Zohydro.
“We ask you to put the public’s health ahead of industry efforts. In the midst of a severe drug addiction epidemic, fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the FED UP! Coalition wrote in a letter to FDA Commissioner Margaret Hamburg.
Several congressmen and the attorneys general from 28 states and the District of Columbia have also asked the FDA to reconsider its decision.
“You’ve all heard it, if you follow our company. There’s a well-orchestrated campaign about the concerns of people who may have strong emotions and bad past experiences about these products,” said Hawley.
“We’re most concerned about some of the inaccurate, incomplete or even misleading information, and quite honestly in my opinion, some fairly inappropriate comments that have been made about the company and our business practices.”
Some of the sharpest criticism of Zogenix has been over its decision to launch Zohydro without an abuse deterrent formula to discourage drug abusers from crushing or liquefying the painkiller so it can be snorted or injected.
The company said it was making “excellent progress” towards developing an abuse deterrent formulation, but it was at least two years away.
“We are making solid progress on two separate projects, with the target of having an approved product by the end of 2016,” said Farr.
One project would add an abuse deterrent to Zohydro capsules. The other formulation would be applied to Zohydro tablets. The drug is currently being sold in capsule form only.
Few benefits and many risks will result from the marketing of Zohydro, according to Richard Blondell, MD, vice chair for addiction medicine at the University at Buffalo.
“We already have a prescription drug problem and the way this drug is packaged makes it easy to abuse. Zohydro is just another opiate product in a market that’s already flooded with them,” said Blondell, a professor of family medicine in the UB School of Medicine and Biomedical Sciences.
“Why introduce a new product that will pose unnecessary risks for those who are already abusing prescription drugs as well as for patients who could become addicted simply by being prescribed these drugs?”
Zogenix recently formed an independent panel of outside experts to monitor the prescribing of Zohydro, as well as any abuse or misuse that may occur. The company is also offering through its website a free locking cap for patients to use on their prescription bottles.
Net loss for Zogenix during the fourth quarter 2013 was $35.6 million, or $0.28 per share, compared to a net loss of $0.6 million, or $0.01 per share, for the fourth quarter 2012. Net loss for the full year 2013 was $80.9 million, or $0.74 per share, compared to a net loss of $47.4 million, or $0.59 per share, for 2012.
Zogenix is not providing financial guidance for 2014. However, the company expects to spend $110 – $120 million on research and development, administrative expenses and sales in 2014. Zogenix has expanded its sales force to 150 sales representatives to help launch Zohydro.