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The420Guy
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Apr. 1, 00
PRNewswire
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First Time a Schedule II Drug Down-Scheduled...
Roxane Laboratories, Inc. and Unimed Pharmaceuticals, Inc. today announced that California state authorities have rescheduled MARINOL(R) (dronabinol) from a Schedule II to a Schedule III drug, thus easing the prescribing restrictions imposed on physicians choosing to prescribe the medication.
MARINOL, which has been proven a safe and effective drug-medication for the treatment of anorexia or appetite loss associated with weight loss in AIDS, is synthetic THC, the active ingredient found in marijuana. For this reason, it was originally classified as a Schedule II drug. Schedule II drugs are tightly controlled substances that require many prescribing restrictions such as triplicate prescriptions and no refills. The reclassification to a Schedule III drug will now allow doctors and patients in California easier access to the benefits of MARINOL.
The decision to reschedule MARINOL was made on the Federal level on July 2, 1999. This change in schedule status was greatly influenced by the support of the Food and Drug Administration (FDA), the National Institute on Drug Abuse (NIDA), and the findings of a review study completed by the Haight Ashbury Free Clinics. This review concluded that MARINOL has a low abuse potential and does not warrant being included in the same scheduling status as drugs such as morphine and oxycodone. "This is a win-win situation for doctors and patients in California," said Gary Cohan, M.D. and vice president of Pacific Oaks Medical Group in Beverly Hills, California -- the largest private medical practice in the U.S. devoted to HIV treatment and research. "Marinol has the ability to provide the benefits of appetite stimulation -- without some of the adverse effects associated with smoking marijuana." According to the California Department of Health, there are currently more than 100,000 California residents living with AIDS.
The California state legislative bill, SB-550, supporting the rescheduling of MARINOL was authored by Senator Patrick Johnston (D-Stockton). "Our goal is to provide easier access to effective therapies for Californians," said Sen. Johnston. "Today's rescheduling of Marinol makes this important drug more accessible to those who need it and benefit from it," he continued. Johnston's bill was signed into law by Governor Gray Davis on Wednesday, March 29. David Smith, M.D., one of the authors of the Haight Ashbury review study and past president of the American Society of Addiction Medicine, noted, "Our study clearly found that there was no abuse of Marinol during the 13 years it has been on the market. This means that we can comfortably reschedule Marinol without increasing illicit use of the drug." In clinical trials, and in use by thousands of patients, MARINOL has been shown to stimulate appetite in significant numbers of patients. "This drug works well with combination antiretroviral therapy and is highly effective in helping a patient get back his appetite," added Cohan. "With proper titration I can achieve the desired results with little or no side effects and unlike marijuana, it can be used in a work setting, meaning that I can get my patients back to work and into their old routine again."
In 1996, California voters passed Proposition 215 supporting the use of smoking illegal marijuana for medical purposes. Similar ballot initiatives are becoming more common in states across the country. As a result, attention has been drawn to the beneficial properties of MARINOL and its role as a FDA-approved, pure, medicinal alternative to smoked marijuana.
MARINOL is marketed by Roxane Laboratories and co-promoted with Unimed Pharmaceuticals, Inc. Marinol was first brought onto the market by Roxane in 1985 for the treatment of cancer chemotherapy induced nausea and vomiting that is unresponsive to traditional medications. In 1992, the FDA approved Roxane and Unimed's supplemental new drug application for MARINOL for the treatment of appetite loss or anorexia associated with weight loss in AIDS patients. MARINOL is generally well-tolerated with side effects usually being mild and reversed by a lowering of the drug's dose. The most common side effects involve the central nervous system and include sleepiness, dizziness and euphoria (or giddiness).
For full prescribing information on Marinol, call 614-241-4114 or see "Product Information" on the Marinol web site at: MARINOL (dronabinol) | Official Site from AbbVie Inc.. Roxane Laboratories, Inc. West-Ward Pharmaceuticals is a leading manufacturer of ethical human pharmaceutical products with a strong commitment to palliative care. The Company is a wholly owned subsidiary of Boehringer Ingelheim Corporation, located in Ridgefield, CT, and is part of the Boehringer Ingelheim worldwide group of companies. Boehringer Ingelheim, headquartered in Ingelheim (Germany) ranks among the top 20 pharmaceutical companies in the world. It reported revenues exceeding DM 8.7 billion (US$4.97 billion) in 1998. The corporation has more than 140 affiliated companies and it conducts business on every continent. Its product range is focused on human pharmaceuticals -- hospital, prescription and self-medication -- as well as animal health. The company has substantial research and development, production, and distribution facilities around the globe. In 1998 Boehringer Ingelheim spent DM 1.6 billion (US$902 million) on R&D, equivalent to 18 % of total sales. Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of hypertension, endocrinology, urology, HIV and other infectious diseases. Unimed currently co-promotes Marinol(R) (dronabinol) and markets Teveten(R) (eprosartan mesylate) for the treatment of hypertension, Anadrol(R)-50 (oxymetholone) for the treatment of various anemias, and Maxaquin(R) (lomefloxacin HCl), a broad-spectrum quinolone antibiotic, for both complicated and uncomplicated urinary tract infections.
Contact: Kelli Schobelock, Public Affairs of Roxane Laboratories, Inc., 614-272-4774, or fax, 614-274-0974, kschobelock@col.boehringer-ingelheim.com; or Peter George, 212-886-3491, or Maureen Byrne, 212-886-3312, both of GCI Healthcare, fax, 212-886-3291, for Roxane Laboratories, Inc. Columbus, Ohio & Deerfield, Illinois
PRNewswire Copyright © 1995-2000 Excite Inc.
PRNewswire
****
First Time a Schedule II Drug Down-Scheduled...
Roxane Laboratories, Inc. and Unimed Pharmaceuticals, Inc. today announced that California state authorities have rescheduled MARINOL(R) (dronabinol) from a Schedule II to a Schedule III drug, thus easing the prescribing restrictions imposed on physicians choosing to prescribe the medication.
MARINOL, which has been proven a safe and effective drug-medication for the treatment of anorexia or appetite loss associated with weight loss in AIDS, is synthetic THC, the active ingredient found in marijuana. For this reason, it was originally classified as a Schedule II drug. Schedule II drugs are tightly controlled substances that require many prescribing restrictions such as triplicate prescriptions and no refills. The reclassification to a Schedule III drug will now allow doctors and patients in California easier access to the benefits of MARINOL.
The decision to reschedule MARINOL was made on the Federal level on July 2, 1999. This change in schedule status was greatly influenced by the support of the Food and Drug Administration (FDA), the National Institute on Drug Abuse (NIDA), and the findings of a review study completed by the Haight Ashbury Free Clinics. This review concluded that MARINOL has a low abuse potential and does not warrant being included in the same scheduling status as drugs such as morphine and oxycodone. "This is a win-win situation for doctors and patients in California," said Gary Cohan, M.D. and vice president of Pacific Oaks Medical Group in Beverly Hills, California -- the largest private medical practice in the U.S. devoted to HIV treatment and research. "Marinol has the ability to provide the benefits of appetite stimulation -- without some of the adverse effects associated with smoking marijuana." According to the California Department of Health, there are currently more than 100,000 California residents living with AIDS.
The California state legislative bill, SB-550, supporting the rescheduling of MARINOL was authored by Senator Patrick Johnston (D-Stockton). "Our goal is to provide easier access to effective therapies for Californians," said Sen. Johnston. "Today's rescheduling of Marinol makes this important drug more accessible to those who need it and benefit from it," he continued. Johnston's bill was signed into law by Governor Gray Davis on Wednesday, March 29. David Smith, M.D., one of the authors of the Haight Ashbury review study and past president of the American Society of Addiction Medicine, noted, "Our study clearly found that there was no abuse of Marinol during the 13 years it has been on the market. This means that we can comfortably reschedule Marinol without increasing illicit use of the drug." In clinical trials, and in use by thousands of patients, MARINOL has been shown to stimulate appetite in significant numbers of patients. "This drug works well with combination antiretroviral therapy and is highly effective in helping a patient get back his appetite," added Cohan. "With proper titration I can achieve the desired results with little or no side effects and unlike marijuana, it can be used in a work setting, meaning that I can get my patients back to work and into their old routine again."
In 1996, California voters passed Proposition 215 supporting the use of smoking illegal marijuana for medical purposes. Similar ballot initiatives are becoming more common in states across the country. As a result, attention has been drawn to the beneficial properties of MARINOL and its role as a FDA-approved, pure, medicinal alternative to smoked marijuana.
MARINOL is marketed by Roxane Laboratories and co-promoted with Unimed Pharmaceuticals, Inc. Marinol was first brought onto the market by Roxane in 1985 for the treatment of cancer chemotherapy induced nausea and vomiting that is unresponsive to traditional medications. In 1992, the FDA approved Roxane and Unimed's supplemental new drug application for MARINOL for the treatment of appetite loss or anorexia associated with weight loss in AIDS patients. MARINOL is generally well-tolerated with side effects usually being mild and reversed by a lowering of the drug's dose. The most common side effects involve the central nervous system and include sleepiness, dizziness and euphoria (or giddiness).
For full prescribing information on Marinol, call 614-241-4114 or see "Product Information" on the Marinol web site at: MARINOL (dronabinol) | Official Site from AbbVie Inc.. Roxane Laboratories, Inc. West-Ward Pharmaceuticals is a leading manufacturer of ethical human pharmaceutical products with a strong commitment to palliative care. The Company is a wholly owned subsidiary of Boehringer Ingelheim Corporation, located in Ridgefield, CT, and is part of the Boehringer Ingelheim worldwide group of companies. Boehringer Ingelheim, headquartered in Ingelheim (Germany) ranks among the top 20 pharmaceutical companies in the world. It reported revenues exceeding DM 8.7 billion (US$4.97 billion) in 1998. The corporation has more than 140 affiliated companies and it conducts business on every continent. Its product range is focused on human pharmaceuticals -- hospital, prescription and self-medication -- as well as animal health. The company has substantial research and development, production, and distribution facilities around the globe. In 1998 Boehringer Ingelheim spent DM 1.6 billion (US$902 million) on R&D, equivalent to 18 % of total sales. Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of hypertension, endocrinology, urology, HIV and other infectious diseases. Unimed currently co-promotes Marinol(R) (dronabinol) and markets Teveten(R) (eprosartan mesylate) for the treatment of hypertension, Anadrol(R)-50 (oxymetholone) for the treatment of various anemias, and Maxaquin(R) (lomefloxacin HCl), a broad-spectrum quinolone antibiotic, for both complicated and uncomplicated urinary tract infections.
Contact: Kelli Schobelock, Public Affairs of Roxane Laboratories, Inc., 614-272-4774, or fax, 614-274-0974, kschobelock@col.boehringer-ingelheim.com; or Peter George, 212-886-3491, or Maureen Byrne, 212-886-3312, both of GCI Healthcare, fax, 212-886-3291, for Roxane Laboratories, Inc. Columbus, Ohio & Deerfield, Illinois
PRNewswire Copyright © 1995-2000 Excite Inc.
