Things aren’t looking great for Zogenix Inc. nor its flagship drug, the powerful narcotic painkiller Zohydro. The company’s stock recently plummeted on news that a competitor just might have built a better mousetrap — drug — and could soon emerge on the market.
Meanwhile, two U.S. senators are actively petitioning Health and Human Services Secretary Kathleen Sebelius to revoke approval for the San Diego company’s potent drug — citing its potential for abuse and a questionable “pay-for-play” approval process.
Zohydro is the only approved drug that consists of pure hydrocodone — most are cut with acetaminophen, the active ingredient in Tylenol. It is meant to compete with prescription painkillers like Vicodin, though Zohydro is about 10 times stronger.
Purdue Pharma LP, the Connecticut company that makes OxyContin, announced that it’s applying for regulatory approval for an abuse-resistant version of its drug. Zogenix (Nasdaq: ZGNX) only recently received approval for Zohydro, but it was by the skin of its teeth — a Food and Drug Administration advisory committee voted against its approval because it has a high potential for abuse.
Purdue Pharma, meanwhile, is developing a new pill that’s difficult to crush, snort
or inject. Zohydro at present doesn’t have any of these safeguards, although CEO Roger Hawley told me in a recent interview that the company is developing abuse-deterrent versions. They aren’t slated for release until 2016, however — by which time this new OxyContin formulation could be on the market.
Zogenix began a small wave of distribution just this month in select pharmacies. The company raised $60 million in a secondary offering in November — right on the heels of its FDA approval — to commercialize Zohydro.
Furthermore, if a better alternative to Zogenix emerges, the FDA has the authority to remove less-efficacious or safe drugs from the market. And two U.S. senators asked the FDA just this month to pull Zohydro.
“If and when they, 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 non-abuse formulations are removed from the market,” Bob Rappaport, director of pain drugs at the FDA, said in Zohydro’s Oct. 25 review for approval.
Sens. Charles Schumer, D-N.Y., and Joe Manchin, D-W.Va., wrote letters to Sebelius petitioning for the revocation of Zohydro.
“Simply put, the FDA’s approval of Zohydro ER, in its current form, must be stopped before this dangerous drug is sold to the public,” Manchin wrote March 10.
Drug overdose rates in the U.S. have tripled since 1990 — an unprecedented rise that parallels a 300 percent increase in the sale of strong painkillers, according to the Centers for Disease Control and Prevention. In 2008, prescription pills led to 14,800 overdose deaths — more than cocaine and heroin combined.
Also interesting, Manchin continued in his letter that he was “deeply troubled” that Zohydro’s approval could be linked to allegations that the FDA allowed certain drugmakers to pay as much as $35,000 to meet privately with FDA officials.
These “pay-to-play” allegations were first aired by the Washington Post in October, and they remain a black mark on the public perception of the FDA, though it denies that anything improper occurred.
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San Diego-based mobile health care software developer PatientSafe Solutions Inc. has received a $3 million investment from Telus Ventures, the investment arm of Canadian telecom giant Telus Communications Co. (TSE: T).
The company closed a $27 million Series C round this past September. Other investors in the company include the Merck Global Health Innovation Fund, Camden Partners, TPG Biotech, Psilos Group and EDBI.
The investment will help PatientSafe commercialize its clinical workflow platform, PatientTouch. The system consolidates electronic health record information and makes it accessible on a mobile device, like a smartphone or tablet, enabling caregivers to get information and communicate from a patient’s side.
The deal also will grant Telus exclusive rights to resell the PatientTouch system in Canada, and it will introduce PatientSafe to international telecommunications partners.
The privately held company is headquartered in Sorrento Valley and employs about 70. Its software is being used in more than 75 hospitals around the U.S.
Send news about locally based health care organizations, biotech and clean-tech to Meghana Keshavan at email@example.com. She can be reached at 858-277-6359.