Zogenix: No Decision on Zohydro Painkiller Until Summer

Zogenix: No Decision on Zohydro Painkiller Until Summer

The Food and Drug Administration has notified Zogenix Inc. (NASDAQ: ZGNX) that it won’t reach a final decision on the company’s powerful new painkiller, Zohydro, until this summer.

“To our knowledge this sort of delay is unprecedented,” Roger Hawley, CEO of Zogenix, said during a conference call announcing the company’s first quarter results.

The FDA had already informed Zogenix in late February that it would be unable to reach a decision by a March 1 target date. The agency gave no explanation for the added delay.

“We recently had an update call with the FDA regarding the status of the Zohydro ER new drug application (NDA). On the call, the FDA indicated that they are preparing to take action on the Zohydro NDA in the summer 2013. While they declined to provide any specific reasons for the delay, we have concluded the FDA are working on several broader opioid-related issues that need to be addressed,” Hawley said.

ZohyrdoIf approved, Zohydro would be the first pure hydrocodone painkiller sold in the U.S. Combination versions of hydrocodone, such as Vicodin, typically contain acetaminophen and require dosing every 4 to 6 hours. Extended release Zohydro could be taken just twice a day.  About 47 million patients received prescriptions for hydrocodone products last year, according to the FDA.

Late last year a panel of pain experts advised the FDA to reject Zohydro because of potential abuse of the opioid painkiller. The vote was 11-2 with one abstention.

“If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” FDA staff reviewers wrote in a report.

The FDA is not obligated to accept the findings of its advisory committees or staff. The fact that a final decision was delayed beyond March 1 is being interpreted by some as a sign that FDA may still approve Zohydro to treat moderate to severe pain.

If approved, Zohydro ER would be classified as a Schedule II drug, making it subject to stricter prescribing and dispensing rules. All hydrocodone products are currently classified as Schedule III drugs, although the FDA is considering reclassification of hydrocodone as a Schedule II controlled substance.

“We are quite happy to be on the Schedule II. If the other products are rescheduled, we would certainly hope that patients have adequate resources to gain access to physicians who could prescribe their products,” Hawley told analysts according to a transcript on Seeking Alpha.

“There are literally hundreds of thousands if not millions of patients that would be affected. So I don’t know the outcome there, but we don’t see a legitimate reason why that factor is a cause to continue a delay where we have no known issues with the review division.”

While “disappointed” with the delay, Hawley said Zogenix would be prepared to launch Zohydro three to four months after its potential approval.

“Although FDA action on Zohydro ER is uncertain, we view the risk/reward profile on ZGNX shares as favorable,” Wells Fargo analyst Michael Tong said in a note to clients.

Tong rates the stock “outperform” with a target price of $3.00 to $3.50, nearly double its current share price. He says the company will need to raise more cash – possibly by selling more shares — by the end of the year.

“The delay in FDA action on Zohydro ER is a double-edged sword. An early approval could have allowed an equity offering that is less dilutive. The delay makes the equity option less appealing. However, it also permits the company to delay pre-launch and commercialization expenses for Zohydro, thus conserving cash,” Tong said.

Zogenix reported a net loss of $21.1 million, or $0.21 per share, compared to a net loss of $10.3 million, or $0.16 per share, for the first quarter 2012. Revenue declined by over 60% to $7 million from a year earlier.

Authored by: Pat Anson, Editor

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Ben

Well……summer came and went and the FDA still hasn’t made a decision.
The FDA was commissioned to do 2 primary things: 1. Decide if a drug is safe and 2. Decide if the drug is effective.
That’s it, that’s all they’re supposed to do and yet 9 months later they still haven’t decided if they can approve Zohydro or not? What an over-funded over reaching bureaucracy the FDA has become.

paul

Hydrocodone is the only opiate that does not get me sick to my stomach. Oxy dud, Opana dud, Fentanyl dud, Norco, good, but the APAP not good for the liver. This country is run by the actions of a criminal minority, the schools, gun laws, now drug laws.

Gerald

I AM NOT A DRUGGIE! NOR DO I CARE ABOUT GETTING HIGH! I WANT TO FUNCTION AS A NORMAL HUMAN BEING! WITH PAIN THAT ISN’T POSSIBLE! I THINK ALL GOVERNMENT BUREAUCRACY’S SHOULD BE ABOLISHED, BROKEN, AND CRUMBLED INTO DUST! THESE PEOPLE WHO THINK THEY KNOW WHAT’S BETTER FOR ME ARE NOTHING BUT OVERLY PAID CONTROL FREAKS! THEY DON’T CARE ABOUT ME OR YOU! THEY DON’T KNOW PAIN! I THINK ALL MEDICINE WHETHER LEGAL OR NOT SHOULD BE AVAILABLE TO ANYONE! TOO MUCH MONEY IS GOING TO DRUG COMPANIES, LAWYERS, JUDGES, PRISONS AND ORGANIZED CRIME! LEGALIZE IT ALL! THE CRIME RATE WILL DROP LIKE A LEAD BALLOON! AFTER PROHIBITION THE CONSUMPTION RATE WENT DOWN AS WELL AS CRIME CONCERNING IT! WE WON’T BE WAREHOUSING INMATES AND SAVING BILLIONS ON THIS LOST WAR! LEGAL PAIN PATIENTS ARE COLLATERAL DAMAGE VICTIMS OF THIS WAR! WITH BILLIONS TO TRILLIONS OF DOLLARS SAVED THIS CAN BE USED FOR FREE DRUG REHABS AND EDUCATION! THE CRIME RATE AND CONSUMPTION WILL FALL! IT’S HAPPENED IN COUNTIES THAT HAVE DONE THIS TO A CERTAIN DEGREE! INSTEAD OF BUILDING MORE PRISONS AND BUYING MACHINE GUNS TO POLICE OFFICERS! IMAGINE A WORLD WHERE PEOPLE WOULDN’T BE GETTING KILLED FOR A FEW DOLLARS FOR SOMEONE’S ADDICTION! THE PRISON POPULATION WOULD BE 1/3 OF WHAT IT IS TODAY OR LESS. THERE WOULD BE FEWER PRISONS, POLICE, JUDGES, LAWYERS, AND GOVERNMENT BUREAUCRACIES! WE WOULDN’T HAVE DOCTORS ACTING LIKE COPS! REMEMBER WHEN YOU COULD ACTUALLY CONFIDE IN A DOCTOR LIKE YOU WOULD A PRIEST OR RABBI? REMEMBER WHEN YOU WEREN’T GIVEN A HAIR, BLOOD, OR URINE TEST? LIKE A CONVICT ON PAROLE WOULD HAVE DONE! WE ARE PATIENTS NOT CRIMINALS! IF THE WAR WAS WON (WHICH IT WILL NEVER BE) THE ORGANIZED CRIME, JUDGES, LAWYERS, POLICE, AND PRISONS WOULD BE OUT OF WORK! THEY DON’T WANT IT TO STOP BECAUSE THIS IS THEIR BREAD AND BUTTER! THEY ARE MAKING TOO MUCH MONEY FROM DRUGS LEGALLY OR ILLEGALLY! IT’S BEEN GOING ON FOR ALMOST 50 YEARS! DON’T YOU THINK ENOUGH’S ENOUGH? I KNOW THIS ALL SOUNDS AWFULLY CRAZY, BUT BECAUSE OF THIS WAR PAIN PATIENTS SUFFER! THERE ARE A GREAT MANY OF YOU WHO WILL DISAGREE! PROBABLY THE ONES WITHOUT PAIN AND A LOT OF THIS MONEY TO LOSE! THE ONES THAT AGREE JUST TO GET HIGH ARE NOT WHOM I’M TALKING TO! I WAS ONE WHO DISAGREED VEHEMENTLY UNTIL I BECAME WRACKED IN PAIN AND BECAME DYSFUNCTIONAL AND HAD TO DEAL WITH DOCTOR-COPS AND DRUG COMPANIES CHANGING THEIR MED SO THIS OR THAT COULDN’T BE DONE TO IT WHICH MADE IT INEFFECTIVE! WE NEED TO STOP THIS INSANITY BEFORE THIS WAR STOPS US FROM GETTING THE PAIN MEDICINE WE NEED, AND WANT TO LIVE A PAIN FREE LIFE! A LOT OF THESE SAFEGUARDS PLACED ON THESE MEDICINES LOWER IT’S EFFECTIVENESS! WE ALSO NEED TO STOP RUINING LIVES AND KILLING PEOPLE THAT STARTED OUT AS A THRILL AND ENDED UP A DISEASE. THAT’S WHAT ADDICTION IS! I DON’T CARE WHAT NEGATIVE OPINIONS ARE OUT THERE… Read more »

KELLY

THE PEOPLE WHO WANT THIS DRUG PRESCRIBED ARENT THE DRUGGIES. ITS THE ONES WITH PAIN. The people I know who get pain meds dont even have pain, they do it to make money….and they have NEVER heard of the ER Hydrocodone….now the ones that I see in Pain Management they are the people who KNOW what this medication is, and are praying it be approved.
If doctors would start giving a crap and giving people with PAIN medication and stop giving it to the people who want a high than this wouldnt even be a question of denial.

alice guevara

I FEEL THAT I MUST SAY SOMETHING ABOUT THIS, I LIVE WITH CHRONIC PAIN AND BELIEVE ME ITS NOT EASY.I HAVE BEEN PRAYING THAT THIS MEDICATION IS APPROVED.TYLENOL IS GOOD FOR A HEADACHE OR A FEVER ETC,BUT NOT FOR BONE PAIN.I HAVE 2 KNEE REPLACEMENTS,1 HIP REPLACEMENT AND 2 BACK SURGERIES AND I AM 60 YEARS OLD.HYDROCODONE IS A GOOD MEDICATION BUT IS NOT LONG LASTING.I WISH THE PERSON THAT IS AGAINST THIS COULD LIVE IN MY BODY ,SO PLEASE PUT THIS OUT ON THE MARKET AND I HAVE TO AGREE WITH THE OTHER PERSON THAT SAID PEOPLE KILL PEOPLE NOT PILLS.THANK YOU.

Bob

The FDA has to protect people from themselves. People can’t help themselves when it comes to their addictions so they intervene. Totally unfair to the legitimate pain patient, but honestly illegitimate use is a huge problem.

Bob

Please, hydrocodone is already a schedule II substance. The only reason existing hydrocodone products are schedule 3 is because they are all combination products with some opioid sparing pain medicine like APAP

You are so right, Janice. They are going to keep rejecting all of these medicines until there’s nothing left but aspirin, Tylenol and ibuprofen. If these medicines actually killed pain then we wouldn’t have to go to these doctors and pharmacists that look at and treat us pain patients like pond scum. ,I for one, am sick of it !!! Let their children or loved one be suffering. I’ll bet they would want help for them!! Your last statement about addicts couldn’t be more accurate. Someone who abuses pain medicine is going to abuse whatever they can get their hands on. It’s not the pills, its the person!!! Pills don’t kill, people do!!! Lets be fair about this and
do away with alcohol too if we have to lose our meds!!!

Donna Ratliff

If all long acting pain medicines have that polymer filling then any patients who have had bad reactions to it are stuck with no medications for their pain. When will the FDA realize that it doesn’t make any difference if the med has the abuse deterrent or not? The addicts will find something else, while the pain patient who takes as prescribed is the person being harmed here. Pain medication is being catered towards addicts not patients with REAL pain. Most overdoses were by people that weren’t even prescribed. A very small amount were by innocent patients. We are going in reverse in 2013 not forward.

Janice Reynolds

Who was the panel of “pain experts” that wanted to stop this medication? I believe they were mostly is not all PROP members. The members of PROMPT who are more divirse and larger in nmber (as well as basing their opioins on evidence instead of arrogance as PROP members have done) it would have would have been a different story. As people vary as to what works best for them, having another option is very important and helpful. Medications don’t make addicts, an addictive personality does. Don’t punish people with pain (especially since those prescription drug addicts are transfering their allegence to heroin now).