Early next year, if all goes according to plan, doctors will be able to prescribe a new antipsychotic drug for patients with schizophrenia. When that happens, investors in a local pharmaceutical firm will surely breathe a sigh of relief.
While it's almost certain that the compound known as Fanapt will reach pharmacy shelves, the drug's future was anything but clear for most of its 13-year existence. Rockville-based Vanda Pharmaceuticals toiled for years on its development, even after larger drugmakers lost interest and the Food and Drug Administration gave the product a thumbs-down.
"Last year at this time, nobody believed in the company, and nobody believed in the compound," said Mihael H. Polymeropoulos, Vanda's president and chief executive. Today, the company has a deal for Fanapt worth nearly half a billion dollars.
READ MORE @ WASHINGTON POST
Showing posts with label acute schizophrenia symptoms. Show all posts
Showing posts with label acute schizophrenia symptoms. Show all posts
Sunday, November 1, 2009
Friday, August 28, 2009
New Antipsychotic Eases Schizophrenia Symptoms
The novel antipsychotic lurasidone appears to improve acute schizophrenia symptoms without the weight gain or metabolic problems common among second generation agents, according to a preliminary report from the drug's second pivotal trial.
Patients treated with the 40 and 120 mg doses of the drug had reductions of 25.7 and 23.6 points on the Positive and Negative Syndrome Scale (PANSS) total score, significantly greater than the 16.0 decline among placebo treated patients, according to data released by drug developer Dainippon Sumitomo Pharma.
In the phase III PEARL 2 (Program to Evaluate the Antipsychotic Response to Lurasidone) trial, 53% of patients on the lower dose and 47% on the higher dose had at least a 30% improvement on symptom score from baseline whereas only 38% on placebo did.
The company press release also announced that lurasidone met key secondary efficacy endpoints at both doses in the trial, including change from baseline on the Clinical Global Impressions Severity scale (-1.5 and -1.4 versus -1.1, respectively).
The results are expected to be reported in greater detail at the American College of Neuropsychopharmacology meeting later this year.
aread more @ medpage today
Patients treated with the 40 and 120 mg doses of the drug had reductions of 25.7 and 23.6 points on the Positive and Negative Syndrome Scale (PANSS) total score, significantly greater than the 16.0 decline among placebo treated patients, according to data released by drug developer Dainippon Sumitomo Pharma.
In the phase III PEARL 2 (Program to Evaluate the Antipsychotic Response to Lurasidone) trial, 53% of patients on the lower dose and 47% on the higher dose had at least a 30% improvement on symptom score from baseline whereas only 38% on placebo did.
The company press release also announced that lurasidone met key secondary efficacy endpoints at both doses in the trial, including change from baseline on the Clinical Global Impressions Severity scale (-1.5 and -1.4 versus -1.1, respectively).
The results are expected to be reported in greater detail at the American College of Neuropsychopharmacology meeting later this year.
aread more @ medpage today
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