The FDA last week approved a new drug to help alcoholics, and it should be available in a couple of months.
Vivitrol (naltrexone for extended-release injectable suspension), which was developed by Alkermes Inc. and will be marketed primarily by Cephalon Inc., is a once-monthly injectable product indicated for alcohol-dependent patients who are able to abstain from drinking in an outpatient setting and who are not actively drinking when beginning the therapy. Treatment with Vivitrol should be used in combination with support from counseling or group therapy.
Its outright approval has been expected for several months, since the FDA issued an approvable letter late last year requesting preclinical pharmacokinetic data. (See BioWorld Today, Dec. 30, 2005.)
"We really feel like addiction is a real medical condition," Alkermes CEO Richard Pops told BioWorld Today, adding that it is hoped that use of Vivitrol "destigmatizes alcoholism and medicalizes it" in the same way that depression treatment with selective serotonin reuptake inhibitors (SSRIs) led the general public to eventually view that condition as a medically treatable disease rather than a self-control issue.
"We believe Vivitrol will provide physicians with an important tool that could serve as the cornerstone of a treatment protocol that includes psychosocial support," Cephalon Chairman and CEO Frank Baldino said in a conference call, adding that "Vivitrol can change the landscape of the treatment of alcohol dependence in America."
These days, it can be treated with a few pharmaceutical products, though Pops said there are little hard data to support such usage. The principle form of treatment remains "talk therapy," he said, and that underlying approach was "a critical piece" to demonstrating Vivitrol's efficacy.
The approval triggered a $110 million milestone payment to Alkermes, of Cambridge, Mass., per terms of a commercialization agreement signed last summer. Cephalon, of Frazer, Pa., is leading sales and marketing efforts and expects to make the drug available by the end of June. Alkermes is responsible for its manufacturing.
In addition to that milestone payment, the deal is a 50-50 profit-sharing arrangement that provided Alkermes $150 million in up-front cash and could generate up to $220 million more in milestones related to undisclosed sales levels. (See BioWorld Today, June 27, 2005.)
Formerly known as Vivitrex, the drug will be offered as a single-dose, 380-mg intramuscular injection that provides medication over a month. That duration is seen by some physicians as advantageous for patients, as they will not have to debate daily whether to take the drug as part of their treatment for a disease that "impairs decision making," Pops added, later noting that the program's origins go back to research sponsored by the National Institutes of Health to develop a long-acting treatment. "There's a very receptive community in place," he said.
Notably, though, analysts at SG Cowen & Co. cautioned that the once-monthly injection could be a disadvantage based on other physician comments indicating that daily medications could serve as a reminder of treatment goals, despite the inconvenience. In addition, because Vivitrol must be refrigerated and reconstituted prior to use, and delivered in outpatient settings at doctors' offices, it could take a while for facilities to have proper storage in place, Analysts said in a research note.
They forecasted a conservative launch, noting that the firm's addiction psychiatrist consultants have been cautious about the rate of uptake. Their analysis predicted Vivitrol sales of $30 million for the first year and an increase to $85 million a year later, when they estimated the drug would become profitable. Longer term, the analysts calculated $300 million in sales by 2011.
The companies said they would disclose pricing at launch; the Cowen analysts predicted a price ranging between $300 and $500 per month.
It is estimated that more than 18 million Americans abuse or depend on alcohol, and the companies said about 2.2 million of them seek help. The latter group represents Vivitrol's initial target, "those already seeking treatment," Pops said, with Cephalon to field 120 dedicated sales reps supplemented by 28 marketing managers from Alkermes to reach out to 2,000 to 3,000 physicians who actively prescribe treatment for alcohol dependence. The companies also plan to educate counseling groups.
"Creating awareness in underserved markets is one of Cephalon's strengths," Baldino said, later adding that he expects Vivitrol to enter a receptive reimbursement environment in which it is covered as a medical benefit - because of its administration by professionals - rather than as a pharmaceutical benefit.
Vivitrol works by binding to opioid receptors in the brain, and though the precise mechanism at play in reducing alcohol consumption isn't understood fully, the companies pointed to preclinical data suggesting that occupation of the opioid receptors blocks neurotransmitters in the brain that are believed to be involved in alcohol dependence.
The drug's approval was based largely on Phase III efficacy findings showing that patients treated with Vivitrol and psychosocial support demonstrated a greater reduction in days of heavy drinking than those who received support and placebo over six months of treatment. That was the primary endpoint of the double-blinded, randomized study, which defined heavy drinking as five or more drinks per day for men and four or more for women.
The product proved even more effective in a subset of patients who abstained from drinking in the week prior to receiving their first dose of Vivitrol: Those treated with the drug were more likely to maintain complete abstinence without relapse and showed a greater reduction in drinking days, as well as a greater reduction in heavy drinking days, compared to those on placebo.
The drug's label includes a black box warning to caution against liver toxicity associated with the active pharmaceutical ingredient, naltrexone. An oral formulation of naltrexone also has a black box warning, but according to the highlighted warning label, Vivitrol's recommended doses do not appear to be hepatotoxic.
On Thursday, shares in Alkermes (NASDAQ:ALKS) gained 89 cents to close at $21.96. Cephalon's stock (NASDAQ:CEPH) tacked on 40 cents to finish at $60.20. The approval was announced after the market closed, and stock markets were not open Friday.