Alkermes alcoholism drug wins tentative OK
By Stephen Heuser, Globe Staff | December 29, 2005
A much-anticipated alcoholism drug made by Cambridge biotechnology company Alkermes Inc. won conditional approval from federal regulators yesterday, potentially paving the way for it to be made available early next year.
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The drug, Vivitrol, would be the first injection approved to treat alcoholics. Tests have shown the medication, taken once a month, can reduce heavy drinking in patients who are also in counseling.
In an ''approvable letter" issued yesterday, the Food and Drug Administration said Alkermes needed to provide more scientific data and finish negotiating the wording of the drug's label.
In a statement yesterday, Alkermes chief executive Richard Pops said the letter is a ''positive step."
''We look forward to working diligently with the FDA to gain final approval and bring forward Vivitrol as an important new medication for the treatment of alcohol dependence," he said.
Alkermes hopes to turn Vivitrol into the first widespread drug to treat alcoholism. It is based on an existing medicine, naltrexone, which is believed to dampen the powerful ''high" that pushes alcoholics toward their next drink.
By making the drug a monthly injection instead of a daily pill, Alkermes says, the chances for successful therapy are increased, because alcoholics will not be tempted to stop taking their pills.
Tests have shown that Vivitrol injections helped patients decrease the number of ''heavy drinking days" per month.
The drug also has less drastic side effects than at least one other alcoholism drug, which causes nausea if a patient has contact with alcohol.
The drug was formerly called Vivitrex. The name was changed during the FDA review.
Cephalon Inc., which is co-marketing Vivitrol, said yesterday that it expects the drug to be launched in the first half of next year.
Vivitrol could provide a dramatic boost for Alkermes. Analysts have predicted the drug could eventually bring in as much as $300 million a year, which would make the company profitable for the first time in its 19-year history.
But it will face challenges. While doctors increasingly view alcoholism as a clinical disease rather than a behavioral problem, it is only rarely treated with prescription drugs. Alkermes has been attempting to build networks of therapists and doctors, so alcoholics in treatment also have access to a prescriber and are thus more likely to receive the drug.
According to the company, the FDA needs to see data proving the slow-release version of naltrexone works similarly to the version delivered in pills, which has been on the market for years.
It also needs to finalize the drug's label, which could be complicated. Oral naltrexone includes a warning for possible liver damage, which may reduce the number of prescriptions doctors write. The company would not comment yesterday on whether the warning was an issue in negotiations over the label.
A spokesman for Alkermes said there were no specific deadlines for providing the information the FDA requested.
Ian Sanderson, a biotechnology analyst for SG Cowen & Co., said the issues the FDA outlined seemed manageable.
''It's disappointing -- I was expecting a full approval," Sanderson said, ''but it sounds to me like it's a relatively minor issue to be resolved."
BOTTOMS UP! :toast:
By Stephen Heuser, Globe Staff | December 29, 2005
A much-anticipated alcoholism drug made by Cambridge biotechnology company Alkermes Inc. won conditional approval from federal regulators yesterday, potentially paving the way for it to be made available early next year.
Article Tools
The drug, Vivitrol, would be the first injection approved to treat alcoholics. Tests have shown the medication, taken once a month, can reduce heavy drinking in patients who are also in counseling.
In an ''approvable letter" issued yesterday, the Food and Drug Administration said Alkermes needed to provide more scientific data and finish negotiating the wording of the drug's label.
In a statement yesterday, Alkermes chief executive Richard Pops said the letter is a ''positive step."
''We look forward to working diligently with the FDA to gain final approval and bring forward Vivitrol as an important new medication for the treatment of alcohol dependence," he said.
Alkermes hopes to turn Vivitrol into the first widespread drug to treat alcoholism. It is based on an existing medicine, naltrexone, which is believed to dampen the powerful ''high" that pushes alcoholics toward their next drink.
By making the drug a monthly injection instead of a daily pill, Alkermes says, the chances for successful therapy are increased, because alcoholics will not be tempted to stop taking their pills.
Tests have shown that Vivitrol injections helped patients decrease the number of ''heavy drinking days" per month.
The drug also has less drastic side effects than at least one other alcoholism drug, which causes nausea if a patient has contact with alcohol.
The drug was formerly called Vivitrex. The name was changed during the FDA review.
Cephalon Inc., which is co-marketing Vivitrol, said yesterday that it expects the drug to be launched in the first half of next year.
Vivitrol could provide a dramatic boost for Alkermes. Analysts have predicted the drug could eventually bring in as much as $300 million a year, which would make the company profitable for the first time in its 19-year history.
But it will face challenges. While doctors increasingly view alcoholism as a clinical disease rather than a behavioral problem, it is only rarely treated with prescription drugs. Alkermes has been attempting to build networks of therapists and doctors, so alcoholics in treatment also have access to a prescriber and are thus more likely to receive the drug.
According to the company, the FDA needs to see data proving the slow-release version of naltrexone works similarly to the version delivered in pills, which has been on the market for years.
It also needs to finalize the drug's label, which could be complicated. Oral naltrexone includes a warning for possible liver damage, which may reduce the number of prescriptions doctors write. The company would not comment yesterday on whether the warning was an issue in negotiations over the label.
A spokesman for Alkermes said there were no specific deadlines for providing the information the FDA requested.
Ian Sanderson, a biotechnology analyst for SG Cowen & Co., said the issues the FDA outlined seemed manageable.
''It's disappointing -- I was expecting a full approval," Sanderson said, ''but it sounds to me like it's a relatively minor issue to be resolved."
BOTTOMS UP! :toast:
arty:
