Upcoming Psychiatric Medications in the Pipeline
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 that have been recently approved for prescription, or will likely be approved as a future medication. Some drugs are on the short-term horizon, while others are years away from making it to your pharmacist’s shelf.
Drugs for Depression
Although the Phase III pipeline of drugs for the treatment of depression is deep, including several compounds with new mechanisms of actions, none is expected to be approved in 2009. Pristiq (desvenlafaxine, the major metabolite of venlafaxine), Wyeth’s follow- up to Effexor (venlafaxine), was approved for depression in adults by the FDA in March and could gain ground in the clinic next year.
AstraZeneca submitted an sNDA in May for Seroquel XR for the treatment of generalized anxiety disorder, which was the first submission of an atypical antipsychotic medication for this indication. In February, the company submitted an sNDA for Seroquel XR for the treatment of depression.
In September, LaboPharm submitted an NDA for DDS-04A for the treatment of depression. This compound is the well-known antidepressant trazodone a 5-HT2 receptor antagonist, formulated for once-daily administration. The NDA was based on data from five pharmacokinetic studies and a North American study that included more than 400 patients.
New drugs on the horizon for late 2009/2010 U.S. approval include Valdoxan (agomelatine), which is in development by Novartis and Servier, and Saredutant (SR 48968), a Sanofi-Aventis compound. Valdoxan, which has a novel mechanism of action—melatonin (MT1 and MT2) receptor agonist and 5-HT2C receptor antagonist—and an attractive side-effects profile (i.e., no sexual dysfunction or weight gain), is anticipated.
Novartis is currently conducting four large-scale Phase III trials in the United States, all of which are scheduled to complete in 2009. A U.S. NDA might be submitted in 2009. Saredutant, a neurokinin-2 (NK2) receptor blocker, is well tolerated but has produced mixed results in long-term Phase III trials. Sanofi-Aventis will decide on regulatory submissions based on the results of two ongoing trials assessing saredutant in combination with escitalopram and paroxetine, which are scheduled for completion in the first half of 2009.
Drugs for Bipolar Disorder
Longer-acting injectable and oral formulations of approved atypical antipsychotic medications are the focus of late-stage drug development for bipolar disorder.
Janssen is currently marketing Risperdal Consta, a long-acting, injectable formulation of risperidone for the treatment of schizophrenia. The drug was developed by combining risperidone with the Alkermes’ Medisorb delivery system to maintain a therapeutic drug concentration when administered once every two weeks.