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Jul 24 2007, 4:05 PM EST

Targacept Presents Data from TRIDMAC(TM) Trial Showing Positive Effects of Mecamylamine as Augmentation Treatment for Depressed Patients

News source: Business Wire

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics(TM), today presented positive research findings at the 2007 Summer Meeting of the British Association for Psychopharmacology (BAP). The data suggest that an add-on treatment of mecamylamine hydrochloride, a broad spectrum nicotinic antagonist, improved symptoms of depression in patients who were inadequate responders to first-line citalopram therapy.

"NNR antagonists like mecamylamine may be an important new therapy for treating this group of depressed patients with high unmet medical need," said Geoffrey C. Dunbar, M.D., Vice President of Clinical Development and Regulatory Affairs at Targacept. "The promise of the NNR mechanism as augmentation is particularly encouraging in light of the STAR*D study, which found that less than a third of patients became symptom free with first-line citalopram therapy." Dunbar also noted that per the Sheehan Irritability Scale (SIS), the data showed a statistically strong advantage in the improvement of irritability, which is a common feature of depression. The SIS is a clinical rating scale used to assess the extent to which emotional symptoms such as irritability, frustration, edginess, moodiness, anger with self, anger with others, and temper are present.

Mecamylamine represents a new class of promising antidepressant medications that target the brain's neuronal nicotinic receptors (NNRs). Targacept's depression program also includes TC-5214, one of the enantiomers of mecamylamine hydrochloride and a preclinical product candidate as an augmentation therapy, and TC-2216, a product candidate as a monotherapy for depression and anxiety disorders that is currently in an ongoing Phase I clinical trial.

The Sequenced Treatment Alternatives to Relieve Depression study, or STAR*D, funded by the National Institute of Mental Health (NIMH) was the nation's largest study of treatment-resistant depression. According to the NIMH, if a patient does not respond to a particular treatment, his or her options generally consist of trying an augmentation therapy or switching to another medication. Currently, there are no approved augmentation therapies for depression.

The Targacept study included an open label citalopram hydrobromide phase and a subsequent double blind, placebo controlled phase in which the effects of mecamylamine taken with citalopram, a treatment combination known as TRIDMAC(TM), were evaluated in patients who did not respond adequately to citalopram alone. In the trial, the treatment combination of mecamylamine and citalopram was generally well tolerated. Also, patients showed greater improvement on symptoms of depression and irritability when augmented with mecamylamine, as compared to placebo. Patients for the trial were recruited from nine outpatient facilities, one in the U.S. and eight in India. Of the 472 subjects screened, 450 entered the trial and 192 were randomized to double blind medication.

The BAP poster is available on the Targacept website at www.targacept.com.

About Targacept

Targacept is a clinical-stage biopharmaceutical company that discovers and develops NNR Therapeutics(TM), a new class of drugs for the treatment of central nervous system diseases and disorders. Targacept's product candidates selectively modulate neuronal nicotinic receptors that serve as key regulators of the nervous system to promote therapeutic effects and limit adverse side effects. Targacept has product candidates in development for Alzheimer's disease and cognitive deficits in schizophrenia, pain, and depression and anxiety disorders, as well as multiple preclinical programs. Targacept is located in Winston-Salem, North Carolina. Targacept's news releases are available on its website at www.targ

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