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Two new drugs approved for opiate addiction

Two new weapons against drug addiction will soon be available. On Oct. 8, the Food & Drug Administration approved two buprenorphine products, Suboxone and Subutex, indicated specifically for treatment of opiate dependence. Both products are sublingual tablets manufactured by Reckitt Benckiser, a British company known mostly for OTCs and cleaning products. They will be marketed by Schering-Plough.

Suboxone contains buprenorphine, a semisynthetic, partial opiate agonist, and naloxone, an opioid antagonist. Subutex contains buprenorphine only. Subutex was the first product to be developed, and Reckitt Benckiser filed a New Drug Application for it in 1997. Concerns over abuse potential led the FDA to request the addition of naloxone. This turned out to be complicated chemically, but the company was able to develop the formulation. The NDA for the combination product, Suboxone, was filed in 1999.

The FDA also suggested the Drug Enforcement Administration change the schedule of buprenorphine. In preparation for the approval of the two drugs, DEA moved buprenorphine from a Schedule V designation to Schedule III. Although the narcotic is not considered to have the dependence potential of other opiates, such as methadone and oxycodone, there is still a risk the drug could be abused.

Reckitt Benckiser is going to great lengths to limit abuse of Suboxone and Subutex. Once the products reach the market, the company will conduct an extensive surveillance program to determine the extent of abuse of the products, if any. This will include surveys of physicians and treatment facility staff and monitoring of media, chat rooms, and Web sites. In addition, the company will have several field researchers interviewing street drug users, law enforcement officers, and others to find out whether the drugs are being diverted or abused. Information obtained from these and other studies will be reported to the FDA for review.

The good news for physicians and pharmacists is that treatment with the buprenorphine products will not be limited to specialized clinics, as it has been with methadone. Physicians who have met specific training requirements may apply to the Substance Abuse and Mental Health Services Administration (SAMHSA) for waivers to prescribe Subutex and Suboxone. Approved physicians will receive a unique identification number from DEA. This DEA number will be different from the one they receive to prescribe other controlled substances.

Physicians with the proper waivers and DEA number can then prescribe buprenorphine treatment for up to 30 patients, and they may do this in the privacy of their offices. Induction of therapy will likely consist of Subutex, which the patients must take daily under supervision by their physicians. After initiation of treatment, patients may then receive prescriptions for Suboxone, which they may take daily on their own once stabilized.

Both products will be available from pharmacies, so R.Ph.s will need to be familiar with the drugs and the legal requirements for dispensing them. Some physicians may keep Subutex stocked in their offices. Others may give their patients coupons, along with prescriptions for Subutex, which may be redeemed and dispensed by pharmacies. Patients must then take the medication to their physicians' offices for administration. Suboxone may be dispensed to patients for maintenance therapy.

In all cases, pharmacies may fill only Rxs for Subutex and Suboxone that are written by physicians with the required waivers and DEA number. Pharmacists may call SAMHSA at (866) BUP-CSAT to see whether physicians have these credentials. According to SAMHSA, about 700 physicians have applied for waivers.

Jillene Magill-Lewis, R.Ph.

The author is a clinical writer based in Washington State.

TIPS TO REMEMBER: Suboxone and Subutex

• These drugs may be prescribed only by physicians approved by the Substance Abuse and Mental Health Services Administration and the Drug Enforcement Administration (in the form of waivers and special DEA numbers).

• The most common side effects of buprenorphine were headache, pain, nausea, and sweating. Withdrawal syndrome was also common, but it occurred less with the drug than with placebo during trials (25% versus 37%).

• Withdrawal effects are possible after termination of chronic Suboxone therapy. However, in clinical studies, these effects were milder and slower in onset than those seen after withdrawal of full opioid agonists.

• Buprenorphine products are not approved for pediatric (under age 16) use. They were also teratogenic in animal studies and have produced withdrawal syndrome in newborns.

• Patients should be cautioned that buprenorphine may affect their ability to drive, operate machinery, etc. Combining this medication with other depressant drugs (e.g., benzodiazepines, alcohol) should be avoided.

Jillene Lewis. Two new drugs approved for opiate addiction.

Drug Topics

2002;21:16.