If this opioid is 400X to 1000X stronger than morphine which is basically used in epidurals then how is it going to pass the FDA approval when this has a huge addiction component to it. I can see it used by the army when severe pain medication is needed pronto and the injection system is way better than the IV system used know, plus the pill form makes it easy for the nurses but I can see the FDA having a problem from the abuse side. I guess controlled properly in only administered care facilities is the answer but does the FDA go further than that in its concerns, especially of late. Please help me out on this with your opinions and thoughts.
Thanks for the answer I was looking for, if this is not given to patients in any circumstances then there's no problem with the FDA but I thought in an article that I read it said that it was easier for a patient to administer the drug itself by the use of the new delivery system. Now having said that I stand to be corrected and I've been a believer from the $3.50/$4.50/$5.50/$6.50 mark and foolish enough not to hold from the beginning and made peanuts having new investor worries. My concern is the way the stock is acting and I missed the $7.40 and had a 10 k buy today @ $7.50 that almost got filled. The one person that keeps saying it's going to $6.00 makes a little sense because this stock has been tanking because when it went over $8.00 I cursed myself for not buying it around the $7.60 mark but I did buy high getting out just in time to not to lose money. The stock is not the problem it's when to get in, so is the market conditions going to bring it lower. The people who bought at $13 I feel sorry for but then again I felt sorry for not holding from $3.50 until then, so I'm so confused about the entry point. I know what it's like to miss the ride but I also know what it's like to be on the other side, as well. Please comment like you have on the last question that cleared one more obstacle in my ADD brain. Thanks for insights and everyone have a good weekend.
You're thinking too hard. If you have followed this stock for as long as you say and you feel comfortable with its prospects going forward, then please don't buy 10K shares all at once or your emotions will dictate what you do with those shares. May I suggest that you scale in so you sleep well at night. Have enough at your first entry point that if it goes up, you're happy and if it goes down, you're happy to add to that position!? Biotechs will rip your heart out unless you have a plan. Hope for the best, plan for the worst works for me! Have a good weekend, also!
Safer than PCA Morphine... More effective than PCA Morphine... Faster acting than PCA Morphine... Improved patient ambulatory abilities over PCA Morphine... Lower labor costs for hospitals... Reduced risk of litigation... Universally liked by patients, physicians and nurses.
The FDA's concern over misused pain medication relates to the prescription of hydrocodone (131 million prescriptions in 2011), not pain relievers used in a clinical setting. Have a good weekend everyone.
re pain administered by the patient/addiction/overdose Issue. I just read on the web site that controls are set on the pump apparatus so the patient can NOT administer more then what the doctor prescribes. What the patient CAN do is administer doses at will with in the range set on the pump by the doctor. It's on the web site...
Precisely, this is not a product doled out to the public in any fashion, the FDA will not be concerned with the use by professionals, in fact Morphine has a greater threat profile......
Sentiment: Strong Buy
FDA approves more powerful, pure hydrocodone drug
FDA approves 1st single-ingredient hydrocodone drug, despite negative expert opinion
Associated PressBy Matthew Perrone, AP Health Writer | Associated Press – 1 hour 47 minutes ago..
PFE 30.61 0.00
ENDP 45.92 +0.35
ZGNX 3.04 +0.80
WASHINGTON (AP) -- The Food and Drug Administration has approved a stronger, single-ingredient version hydrocodone, the widely-abused prescription painkiller.
The agency said Friday it approved the extended-release pill Zohydro ER for patients with pain that requires "daily, around-the-clock, long-term treatment" that cannot be treated with other drugs.
Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis and migraines. The new drug from Zogenix is the first pure hydrocodone drug approved in the U.S.
The approval came as a surprise since the agency's own panel of outside advisers gave the drug an overwhelmingly negative review last year. The panel of pain specialists voted 11-2, with one abstention, against approving the drug, questioning the need for a new form of one of most widely-abused prescription drugs in U.S.
Zohydro's approval was quickly criticized by patient safety advocates who had urged the FDA to reject the drug at the public panel last December.
"We're just going to kill more kids and then the FDA is going to come back and say, 'oh, we made a mistake,'" said Avi Israel of Buffalo, N.Y. Israel's son Michael committed suicide in 2011 while struggling with painkiller addiction. Israel is the founder of a group called, Save the Michaels of the World, which aims to combat painkiller abuse in young people.
In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. Hydrocodone also consistently ranks among most-abused medicines in the U.S., according to the Drug Enforcement Administration.
The drug belongs to a family of medicines known as opiates or opioids because they are chemically similar to opium. Others include morphine, heroin, oxycodone, codeine and methadone.
Friday's news was also blasted by lawmakers on Capitol Hill who have been trying to rein in prescription drug abuse in their home states.
Rep. Bill Keating, D-Mass., said the FDA should have required the drug to contain anti-abuse design features that would make it harder for users to crush the pills and snort or inject them.
"FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features. This is outrageous," Keating said in a statement. "Abuse-deterrent technologies should not be the anomaly, they must be the norm."
In recent years, Purdue Pharma, Pfizer Inc., Endo Health Solutions Inc. and other drugmakers have developed tamper-resistant versions of popular opioid drugs.
The timing of the FDA announcement also drew criticism from safety advocates and lawmakers. Only one day earlier the FDA said it would support stronger restrictions on combination drugs containing hydrocodone, including Vicodin and dozens of other generic formulations.
The drugs currently available mix hydrocodone with non-addictive pain relievers like aspirin and acetaminophen. For decades these drugs have been subject to less rigorous prescribing limits than other prescription painkillers like oxycodone.
Late Thursday, the FDA said it would recommend moving hydrocodone combination drugs from the schedule III class to the schedule II class of medications. The switch means that the drugs can only be prescribed by a physician and cannot be refilled. Currently the drugs can be refilled up to five times by the patient can be and prescribed by nurses and other health care workers.
The DEA had first asked the agency to reclassify the drug a decade ago, and lawmakers and safety advocates had increased their pressure on the agency in recent years.
The FDA said in its announcement Friday that the newly-approved Zohydro would be regulated under the schedule II classification.
The agency is also requiring the drug's manufacturer to conduct studies of Zohydro's potential misuse and abuse when used longer than 12 weeks.
The most common side effects reported in company trials included constipation, nausea, drowsiness, fatigue, dizziness, dry mouth, vomiting and itching.
Shares of San Diego-based Zogenix, Inc. jumped in trading Friday, climbing 80 cents, or 36 percent, to close at $3.04. Earlier shares set a 52-week high of $3.45.