Fight Against Heroin Addiction : Part 4

by Food and Drug Administration (FDA)

(Page 4 of 4)

Technical assistance, training, and financial support to states and communities are also available. For example, when the state of Texas asked for assistance after media criticism of maintenance programs in the state, the center arranged for state and program representatives, treatment experts, and FDA and DEA officials to meet in Texas. The conferees identified system-wide problems and solutions and recommended improvement activities.

The center helped the state of Arkansas open its first program last December in Little Rock, which Lubran says reached three- fourths of the target population within three months. "We enabled them to gain invaluable exposure to quality treatment programs around the country to see how they work, and provided guidance with their state regulations," he says.

Another project educates judges and court administrators on how the programs can serve as alternative sentencing for people convicted of crimes related to heroin use or other drug abuse.

Incentives

As an incentive to firms to develop anti-addiction medications, FDA permits this class of drugs fast-track review and eligibility for orphan drug status, which confers tax credits and research grants. Orphan drugs receive seven years of marketing exclusivity. LAAM is a designated orphan drug.

MDD encourages development of maintenance medications by assisting firms with research. MDD deputy director Frank Vocci, Ph.D., says his division is analyzing data from a study in 736 patients to evaluate the safety and effectiveness of an oral sublingual (administered under the tongue) form of buprenorphine (Buprenex) in blocking heroin's euphoria. The drug is approved as an injectable narcotic analgesic.

A buprenorphine-naloxone formulation also is being developed. Although oral buprenorphine may block heroin's effects, the injected form can produce euphoria. However, injected naloxone (Narcan), approved to treat overdose, blocks the euphoria, inducing withdrawal.

"The idea," Vocci says, "is if the drug is taken as prescribed, the naloxone won't kick in. But if patients abuse it by injecting it, the naloxone effect will predominate."

In another study, MDD tested a sustained-release naltrexone formulation that blocked heroin euphoria up to 30 days. Dosage in future trials will be based on the results of this study, Vocci says. Naltrexone (Trexan) is approved for use with maintenance medication, but not as a maintenance medication itself.

These efforts, along with the new approach that brought LAAM to market, offer hope for more safe and effective maintenance medications, possibly to treat other addictions as well.

While there is no cure for heroin addiction, there is hope for recovery through narcotic maintenance treatment programs. Using legal oral synthetic narcotics, maintenance programs wean addicts off heroin, the first step to stable, productive lives.

Changes on the Way?

In 1992, the Public Health Service asked the Institute of Medicine to study federal regulations on methadone maintenance treatment. According to Richard Rettig, Ph.D., the study director, "We examined evolution of the rules, their role in providing the best treatment, and the role of complementary approaches, such as clinical practice guidelines and formal quality control systems." IOM will publish a report on the study late this year.

IOM already released a report this year on development of anti-addiction medications such as methadone and LAAM. Recommendations included making the Treatment IND route and parallel track mechanism available for anti-addiction medications, and assigning priority to the development of anti-addiction medications through an executive order issued by the president. (The "parallel track" policy allows wider availability of promising investigational drugs — currently, only for certain patients with AIDS or other HIV-related conditions — through protocols without control groups, which are conducted parallel to controlled clinical trials necessary to establish safety and effectiveness.)

In the report, IOM identified reasons why firms are reluctant to develop anti-addiction medications. These included problems related to the limited scientific knowledge about addiction, lack of federal leadership, and an uncertain market environment with issues such as pricing concerns, liability, and limited and uncertain insurance coverage. Suggestions to resolve these and other issues are slated for a later report.

About the Author

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