It’s hard to understand all of the drugs in development for mental disorders, but here are a few that we’ve been able to get a handle on. Some drugs are on the short-term horizon, while others are years away from making it to your pharmacist’s shelf.

Drugs for Depression

Duloxetine, Eli Lilly’s follow-up compound to Prozac, is set to become the next drug to enter the antidepressant market. However, convincing physicians that it is superior to Wyeth’s Effexor may prove challenging. Lilly needs to position duloxetine as an alternative first-line therapy to selective serotonin reuptake inhibitors (SSRIs).

Merck’s NK1 receptor antagonist, aprepitant, is expected to be the first drug from another completely new class of antidepressants to hit the market. Its expected launch in 2006 will precipitate an influx of similar compounds to the market, presenting a major threat to the leading position of first-line therapy SSRIs.

Despite the looming patent expiries of several leading antidepressants by 2008, pharmaceutical companies are finding it increasingly difficult to develop novel compounds to replace these products. New strategies are needed to prevent a decline in the antidepressant market. Companies need to begin focusing on the development of compounds with new modes of action and targeting treatment resistant patients.

mifepristone ( Corlux) (Phase III) by Corcept for Psychotic major depression, Alzheimers

Their lead product candidate is CORLUXTM, for the treatment of the psychotic features of psychotic major depression, a disorder that affects approximately three million people in the United States each year and for which there are no FDA-approved treatments. They have also initiated a clinical study to evaluate the tolerability and efficacy of their medicine in improving cognition in patients with mild to moderate Alzheimer’s disease.

CORLUX, also known as mifepristone, works by selectively blocking the binding of cortisol, a steroid hormone, to one of its two known receptors. Elevated levels and abnormal release patterns of cortisol have been implicated in a broad range of human disorders, including PMD. By modifying the level and release pattern of cortisol within the human body, Corcept believes that CORLUX will be able to treat the psychotic features of PMD more quickly and effectively and with fewer side effects than is possible with currently available treatments.

DOV 216,303 by DOV Pharmaceuticals for depression, anxiety and substance abuse.

CRF Receptor Antagonist by Neurocrine Biosciences for Anxiety and depression

Drugs for Bipolar Disorder

AstraZeneca will be the first company to bring an atypical antipsychotic to the bipolar depression market as a monotherapy, following demonstration of efficacy with quetiapine. Pfizer will maintain a strong schizophrenia franchise by releasing asenapine to buffer the loss in revenue due to genericization of ziprasidone.

Solvay/Wyeth/Lundbeck’s bifeprunox will be the leading market entrant in terms of bipolar disorder specific sales revenue. These companies appear to be seeking initial license for bifeprunox in the bipolar depression indication, a tactic that will both increase the commercial viability of the drug and save time/money.

Despite the commercial success of Lamictal (lamotrigine) and Depakote (valproate), the late-stage bipolar disorder pipeline only includes one anticonvulsant class molecule, Novartis’ licarbazepine.

Drugs for Schizophrenia

By 2015, it is expected that there will be stiff competition from numerous generic atypical antipsychotics for schizophrenia. Product differentiation through improved treatment of negative or cognitive symptoms, partial responders, as well as improved tolerability, and demonstration of cost-effectiveness are essential.Current schizophrenia drug manufacturers are taking measures to buffer the erosion of their products by generics over the forecast period. Of the current players, Datamonitor forecasts that only Pfizer will maintain a strong schizophrenia franchise after the genericization of its marketed drug, with the remaining franchises expected to decline.The potential of Organon/Pfizer’s asenapine in treating negative symptoms will be a key therapeutic and commercial advantage, with the drug forecast to be the leading market entrant in terms of value by 2015. Lundbeck/Solvay/Wyeth’s bifeprunox’s will become the second highest new entrant in terms of value by 2015.

ACP-103 by Acadia for Parkinson’s Disease and Adjunctive therapy for schizophrenia (Hallucinations, Psychoses). Acadia is developing ACP-103, a potent and selective 5-HT2Ainverse agonist, as an adjunctive therapy for schizophrenia. By adding ACP-103 in combination with currently-available antipsychotic drugs they believe that the optimal combination of dopamine receptor blockade and 5-HT2Ainverse agonism can be achieved, which may reduce the side effects associated with these drugs and expand their range of efficacy.

GlyT-1 by NPS Pharmaceuticals is also in development for Schizophrenia.

Drugs for Parkinson’s and Alzheimer’s Diseases

Alzehmed for Alzheimer’s disease — (Neurochem-Canada) — Phase 2-3 Estimated marketing 2006-2007

ACP-103, a proprietary small molecule discovered by Acadia, is in development for treatment of the psychiatric and motoric dysfunction that frequently results from current Parkinson’s disease therapies. ACP-103 is given orally and blocks the activity of the 5-HT2A receptor.

AV201 by Avigin for severe Parkinson’s disease.

Phenserine by Axonyx for Alzheimer’s disease .

VP025 by Vasogen Inc. for Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis. Vasogen is also developing a new class of phospholipid-based drugs designed to interact with APCs to regulate cytokine levels and control inflammation. VP025, the first product candidate from this new class of drugs, is in clinical development for chronic inflammation within the central nervous system that is associated with a number of neurological diseases, including Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (Lou Gehrig’s disease).

Apan by Praecis Pharmaceuticals for Alzheimer’s Disease/

Other Psychiatric Drugs in the Pipeline

Sparlon for ADHD. (Modafinil) — This medication will be indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD). It is a new dose form of Provigil which is used to treat narcolepsy. This drug taken once a day may be as effective as the amphetamines and methylphenidate without the same degree of cardiovascular risk.

Vivitrex (Phase III) by Alkermes for Alcohol Dependence.

ocinaplon by DOV Pharmaceuticals for Generalized Anxiety Disorder.

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