PoOkIeHeAd
Bluelighter
- Joined
- Nov 8, 1999
- Messages
- 334
Alright its time to put up or shut up guys. All the people that say they wanna quit but are doing sub maintenance w/ the intermittent dope use its time to face a real choice. Once you detox you can take one shot of Vivitrol and you wont be able to get high for one month no matter what! It blocks the receptors. I just thought this was relevant for the DS as there are a lot people are here struggling and this could be what you are looking for. If you really wanna quit look to Vivitrol.
http://www.reuters.com/article/idUSN1625620420100916
By Susan Heavey
WASHINGTON, Sept 16 (Reuters) - Alkermes Inc's (ALKS.O) Vivitrol drug to treat alcoholics should be approved to help treat people addicted to opioid painkillers, a U.S. Food and Drug Administration advisory panel said on Thursday.
The FDA panel of outside experts, in a 12-1 vote, said the drug could help a desperate group of people with few options to help kick their dangerous addictions. It could also help the biotech, which gets revenue from just one other product.
Sales could reach $125 million by 2015 if the drug wins wider approval, according to Leerink Swann Research Analyst Steve Yoo. Vivitrol's net sales were $20.2 million for fiscal 2010, compared with $16.9 million in 2009 for Alkermes and its then-partner Cephalon Inc (CEPH.O), according to Alkermes.
"We do need tools," said panelist Betty Tai, director of the Center for Clinical Trials Network at the National Institute on Drug Abuse at the National Institutes of Health. "We do need options, and we have so few options for addiction."
The once-monthly injection was approved for alcohol addicts in 2006, but the biotechnology company is seeking to expand its approval. Formal FDA clearance allows the company to legally market the new use and can also impact insurance reimbursement.
That is key as Alkermes now loses money making the drug, which costs the Cambridge, Massachusetts company about $40 million, said Leerink's Yoo. Price and the fact that patients must get the drug at a doctor's office have so far keep many alcoholics away from using it, Yoo and others have said.
Alkermes shares have risen more than 51 percent so far this year ahead of the anticipated expansion. It is also awaiting an FDA decision on its diabetes drug Bydureon.
On Thursday, its shares were halted ahead of the meeting.
After the vote, Alkermes Chief Executive Richard Pops said the company had not disclosed potential sales for the new use should it win FDA's approval and that it was unclear how it would affect profitability for the so-far money-losing drug.
But he told Reuters that the company had a "fully functional" sales team in place already for the alcohol use and was in a "good position to launch" the wider use.
"We'll definitely walk before we run," he said. The FDA panel's support was "such an important milestone." He added that take up among opioid addicts should be better since many see doctors while most alcoholics rely on counseling and other programs.
A few panel members said they were concerned that the company's bid hinged on just one clinical trial done in Russia, but overall the panel said Vivitrol could be useful.
Vivitrol is a new formulation of naltrexone, which has been used for years in an oral form and is available as a generic. Side effects of Vivitrol can include infections, sleep problems and injection site reactions.
"We need to understand this is an adjunct," said panelist Louis Baxter, a New Jersey physician who backed wider use. "There's no one drug that can be a magic bullet."
FDA officials will consider the panel's recommendation as they make their final approval decision, expected by Oct. 12. (Reporting by Susan Heavey; Editing by Bernard Orr)
http://www.reuters.com/article/idUSN1625620420100916
By Susan Heavey
WASHINGTON, Sept 16 (Reuters) - Alkermes Inc's (ALKS.O) Vivitrol drug to treat alcoholics should be approved to help treat people addicted to opioid painkillers, a U.S. Food and Drug Administration advisory panel said on Thursday.
The FDA panel of outside experts, in a 12-1 vote, said the drug could help a desperate group of people with few options to help kick their dangerous addictions. It could also help the biotech, which gets revenue from just one other product.
Sales could reach $125 million by 2015 if the drug wins wider approval, according to Leerink Swann Research Analyst Steve Yoo. Vivitrol's net sales were $20.2 million for fiscal 2010, compared with $16.9 million in 2009 for Alkermes and its then-partner Cephalon Inc (CEPH.O), according to Alkermes.
"We do need tools," said panelist Betty Tai, director of the Center for Clinical Trials Network at the National Institute on Drug Abuse at the National Institutes of Health. "We do need options, and we have so few options for addiction."
The once-monthly injection was approved for alcohol addicts in 2006, but the biotechnology company is seeking to expand its approval. Formal FDA clearance allows the company to legally market the new use and can also impact insurance reimbursement.
That is key as Alkermes now loses money making the drug, which costs the Cambridge, Massachusetts company about $40 million, said Leerink's Yoo. Price and the fact that patients must get the drug at a doctor's office have so far keep many alcoholics away from using it, Yoo and others have said.
Alkermes shares have risen more than 51 percent so far this year ahead of the anticipated expansion. It is also awaiting an FDA decision on its diabetes drug Bydureon.
On Thursday, its shares were halted ahead of the meeting.
After the vote, Alkermes Chief Executive Richard Pops said the company had not disclosed potential sales for the new use should it win FDA's approval and that it was unclear how it would affect profitability for the so-far money-losing drug.
But he told Reuters that the company had a "fully functional" sales team in place already for the alcohol use and was in a "good position to launch" the wider use.
"We'll definitely walk before we run," he said. The FDA panel's support was "such an important milestone." He added that take up among opioid addicts should be better since many see doctors while most alcoholics rely on counseling and other programs.
A few panel members said they were concerned that the company's bid hinged on just one clinical trial done in Russia, but overall the panel said Vivitrol could be useful.
Vivitrol is a new formulation of naltrexone, which has been used for years in an oral form and is available as a generic. Side effects of Vivitrol can include infections, sleep problems and injection site reactions.
"We need to understand this is an adjunct," said panelist Louis Baxter, a New Jersey physician who backed wider use. "There's no one drug that can be a magic bullet."
FDA officials will consider the panel's recommendation as they make their final approval decision, expected by Oct. 12. (Reporting by Susan Heavey; Editing by Bernard Orr)
