Sales of Zohydro – a controversial new hydrocodone painkiller – are growing steadily, despite efforts in some states to ban or restrict the prescribing of the opioid pain medication.
In a conference call with analysts, the chief executive of San Diego-based Zogenix (NASDAQ: ZGNX) said the reaction from physicians and patients to Zohydro was “overwhelmingly positive,” with no sign that it was being abused, misused or diverted.
“Quite honestly we’ve seen no sign of that. In fact we’re very pleased that although we’re only five months into this we’re actually very pleased with the profile we’ve seen. We have fairly extensive surveillance tools and a group of outside experts who are looking at all the data that is available. So we believe in what we’re doing. We believe it’s worked thus far.” said CEO Roger Hawley.
A wave of controversy has surrounded Zohydro – the first single ingredient hydrocodone painkiller sold in the U.S. — since its introduction in March. Some addiction treatment experts have claimed the new painkiller — which does not come in an abuse deterrent formula — will fuel a new wave of narcotic addiction and overdoses.
So far nearly 15,000 prescriptions for Zohydro have been written by nearly 2,800 prescribers in the U.S.
In the first four weeks of July, there were 4,076 prescriptions for Zohydro, an increase of 74% compared to the first four weeks of April.
Zohydro’s introduction has not been trouble free. The Governor of Massachusetts tried to ban all sales of the drug, but his emergency order was ruled unconstitutional by a federal judge who said it interfered with the authority of the Food and Drug Administration to regulate prescription drugs. Zohydro is already subject to schedule-2 controls under the federal Controlled Substances Act, the most restrictive schedule available for an FDA-approved product.
Other states, such as Vermont, require physicians to thoroughly evaluate patients, get patients to sign a treatment agreement and to check a prescription drug database to see if their patients abused other medications before Zohydro can be prescribed.
The biggest threat to Zohydro may not be restrictions on its use, but competition from bigger drug makers. Both Purdue Pharma and Teva Pharmaceuticals are developing their own “pure” hydrocodone products, but with abuse deterrent properties that make it harder for drug abusers to snort or inject. The FDA has given Purdue’s new drug application a “priority review” and the agency’s decision is expected in October.
FDA officials have suggested that if a new hydrocodone product is approved with anti-abuse properties, Zohydro may be removed from the market.
“If and when (Purdue), or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any formulations (without a deterrent) are removed from the market,” said Bob Rappaport, Director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products.
“There’s no real precedent there. So I cannot give you clarity,” said Zogenix’s CEO when asked if he was worried that Zohydro might be pulled from the market if and when a competing product emerges.
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.
Zogenix, which claims Zohydro is safer because it does not contain acetaminophen, estimates there are 2.4 million patients in the U.S. who use hydrocodone “chronically.”
“It seems to me there’s adequate room for a competitor and there’s plenty of business potential. There are a lot of prescribers of hydrocodone and a lot of patients using it,” said Roger Hawley.
“It’s a very large market and the hydrocodone class has the largest number of patients using the hydrocodone molecule. Oftentimes having a competitive product involved actually can help grow the market. We’re not afraid to compete.”
Hawley said up to 80% of the Zohydro prescriptions dispensed so far have been reimbursed by insurers, including Medicare. The number of Medicare-covered prescriptions is higher than what the company expected.
He said the company was “surprised” to learn last week that Express Scripts Pharmacy was excluding Zohydro from its national preferred drug formulary starting in 2015. Express Scripts customers will still be able to get Zohydro if they have prior authorization, he said.