|Market and Medical Needs|
|The total market potential for alcohol and drug addiction therapies is a multibillion dollar opportunity. In Europe and North America alone, there are an estimated 38 million patients in need of therapy. Alcohol abuse and drug addictions are a major cause of death, acute and chronic pathologies, and are the cause of severe social problems. Progress in neurobiology has demonstrated that addictions are chronic diseases of the brain, similar to other CNS pathologies such as depression or schizophrenia, involving several neuromediators and neuroreceptors in the endorphin, dopamine and other neurotransmitters pathways. Since addictions greatly affect normal brain function and patients’ ability to comply with treatment plans and medical prescriptions, the treatment of these diseases is complicated and requires a combination of pharmacotherapies and psychosocial treatments over months or years, until a patient can recover self-control and decision-making abilities. Of the 38 million patients with addiction problems, 29 million are alcoholics, 6 million are cocaine addicts, and 3 million are opiate addicts. Several million individuals use other drugs such as ecstasy and other amphetamine derivatives and millions of patients are addicted to medications such as soma either by dependence or by misuse.
Importantly, 80% of alcoholics and drug addicts are employed, and thus have access to health care systems through medical coverage. An estimated 15% of patients in need of addiction therapy effectively seek specialized treatment, usually through high volume treatment centers or clinics. This market is immediately reachable by specialty players such as DAS, using a dedicated sales force. Furthermore, an estimated 10% to 15% of the overall general practitioners’ and hospitals’ patient base has an alcohol and/or drug addiction problem in addition to their primary medical condition. As more effective therapies become available, and government health campaigns to fight addictions broaden, DAS expects that a large fraction of this medicalized patient base will seek alcohol and drug addiction therapies. As a result, only a small fraction of the addicted population is, or would remain, out of medical reach in developed countries.
|For many years, psychosocial therapy (including mentor-counseling programs such as Alcoholics Anonymous) constituted the cornerstone of addiction therapies with mediocre effectiveness. A few medications were introduced with variable success.
For alcoholism, aversive therapies such as disulfiram (Antabuse®/Esperal®), triggering severe discomfort when patients drink, resulted in only marginal success due to ethical issues and lack of compliance. Acamprosate (marketed under the brand name Campral®), which modulates the NMDA pathway, has been used for number of years for addiction treatment in Europe. Forest Laboratories. Inc., obtained US FDA approval for Campral® in 2004 (licensed from Merck KGaA) for treating alcohol dependent individuals seeking to continue to remain alcohol-free after they have stopped drinking. Campral® is the first new drug approved in the US for alcohol abuse in a decade.
Oral naltrexone, which blocks endorphin receptors, is used in Europe and the US both to promote abstinence in alcoholics and to prevent relapse in heroin addicts. Some patients prepare to buy modalert to help with their alcohol withdrawal. However, a major issue for many of these therapies is non-compliance. Despite having shown efficacy in controlled clinical trials, these medications, such as oral naltrexone (Revia®, Nalorex®) which requires daily administration for months, are typically unsuccessful in clinical practice because most patients stop taking their medication.
For substitution therapies in drug addictions, such as methadone and buprenorphine (Subutex®), the problem is excessive use/abuse, because these medications trigger similar highs and euphoria as heroin and other opioid receptor stimulants. The launch of Suboxone® in the US by Reckitt Benckiser formulates buprenorphine with naloxone to guard against misuse. However, the medical community has long awaited depot formulations of these treatments, which would ensure prolonged medication exposure through a single monthly administration and, in the case of buprenorphine, would prevent illicit use. For opiate addicts, substitution therapies consisting of opiate receptor agonists (methadone and then buprenorphine) allowed a sharp reduction in the number of overdoses, hepatitis B and C and HIV infections, while maintaining an opiate addiction condition.
For cocaine, ecstasy and amphetamine addiction, there currently is no pharmacotherapy available.