AstraZeneca (NYSE: AZN) announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD). SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy.(1)(2)
MDD affects approximately 14.2 million American adults in a given year, and today it is often treated with antidepressants(3). Selective serotonin reuptake inhibitors, or SSRIs, are among the most commonly prescribed class of antidepressant medications for depression; however, in many cases patients fail to respond adequately to treatment(4). Results from a National Institute of Mental Health study, STAR*D, showed that approximately 63% of patients did not achieve remission with the SSRI citalopram when used as a first-line treatment(4). Additionally, this study reported that overall approximately one-third of patients with MDD failed to achieve study defined remission(4). This approval for SEROQUEL XR provides physicians with a new adjunctive treatment option for patients with MDD who have an inadequate response to their current antidepressant.
READ MORE @ MEDICAL NEWS TODAY
Showing posts with label fda approval. Show all posts
Showing posts with label fda approval. Show all posts
Saturday, December 5, 2009
Wednesday, November 25, 2009
Ziprasidone Okayed for Bipolar Disorder
The FDA has cleared ziprasidone (Geodon) for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.
It joins several other antipsychotic drugs -- including quetiapine (Seroquel), aripiprazole (Abilify), and olanzapine (Zyprexa) -- approved for this indication.
Ziprasidone is also approved for acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for schizophrenia.
The approval as bipolar maintenance therapy follows a a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder, according to the drug's manufacturer, Pfizer.
READ MORE @ MEDPAGE TODAY
It joins several other antipsychotic drugs -- including quetiapine (Seroquel), aripiprazole (Abilify), and olanzapine (Zyprexa) -- approved for this indication.
Ziprasidone is also approved for acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for schizophrenia.
The approval as bipolar maintenance therapy follows a a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder, according to the drug's manufacturer, Pfizer.
READ MORE @ MEDPAGE TODAY
Sunday, November 1, 2009
Long, hard road to marketplace for Vanda drug
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
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
Friday, September 4, 2009
More drug firms doing follow-ups than thought--FDA
More pharmaceutical companies have completed studies required by U.S. health regulators after their products were allowed on the market than previously thought, according to an analysis released on Thursday.
But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.
Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.
For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval.
A 2007 law gave the agency more power to require the follow-up studies and ordered the analysis, which found more drug companies than previously thought had completed their studies. Results of the audit by Booz Allen Hamilton Inc were given to the FDA.
"Most companies are doing these studies and they are submitting the reports," said Dr. John Jenkins, director of the FDA's Office of New Drugs.
READ MORE @ REUTERS
But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.
Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.
For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval.
A 2007 law gave the agency more power to require the follow-up studies and ordered the analysis, which found more drug companies than previously thought had completed their studies. Results of the audit by Booz Allen Hamilton Inc were given to the FDA.
"Most companies are doing these studies and they are submitting the reports," said Dr. John Jenkins, director of the FDA's Office of New Drugs.
READ MORE @ REUTERS
Tuesday, August 25, 2009
Iloperidone Approved as “Second-Generation” Benefits Debated
The FDA recently approved iloperidone (Fanapt, Vanda Pharmaceuticals) for the treatment of schizophrenia, reversing a July 2008 determination that the New Drug Application (NDA) was “not approvable.” An FDA spokesperson explained in an interview in Forbes (May 8), “Vanda provided the FDA with additional data and arguments that led us to reinterpret results of several of their studies.”
The favorable judgment culminated a circuitous product development path. The compound had been developed by Hoechst Marion Roussel, but the rights were sold to Titan Pharmaceuticals in 1997, and then to Novartis in 1998, before Vanda Pharmaceuticals acquired them in 2004. Vanda succeeded in garnering regulatory approval, in large part by redesigning the clinical trials supporting the NDA.
Rather than comparing the efficacy of iloperidone with risperidone and haloperidol, which had not previously favored iloperidone, the new trials compared iloperidone with placebo and used ziprasidone as an active control. In this design, the active agents were shown to have comparable efficacy in improving symptoms measured on the 30-item Positive and Negative Syndrome Scale (PANSS) and were both statistically superior to placebo.
READ MORE @ PSYCHIATRIC TIMES
The favorable judgment culminated a circuitous product development path. The compound had been developed by Hoechst Marion Roussel, but the rights were sold to Titan Pharmaceuticals in 1997, and then to Novartis in 1998, before Vanda Pharmaceuticals acquired them in 2004. Vanda succeeded in garnering regulatory approval, in large part by redesigning the clinical trials supporting the NDA.
Rather than comparing the efficacy of iloperidone with risperidone and haloperidol, which had not previously favored iloperidone, the new trials compared iloperidone with placebo and used ziprasidone as an active control. In this design, the active agents were shown to have comparable efficacy in improving symptoms measured on the 30-item Positive and Negative Syndrome Scale (PANSS) and were both statistically superior to placebo.
READ MORE @ PSYCHIATRIC TIMES
Thursday, August 6, 2009
FDA Okays First Monthly Antipsychotic Drug
The FDA has approved the injectable maintenance drug paliperidone palmitate (Invega Sustenna), making it the first once-monthly, atypical antipsychotic for schizophrenia.
The long-acting drug is approved for both acute and maintenance treatment.
The parent drug -- paliperidone in a once-daily tablet -- is an active metabolite of an old pharmaceutical, the atypical antipsychotic risperidone (Risperdal). (See Invega (paliperidone), Son of Risperdal (risperidone), Wins FDA Okay for Schizophrenia)
Researchers see once-monthly dosing as a potential solution for the medication adherence problems common in schizophrenia, noted Henry A. Nasrallah, MD, of the University of Cincinnati, an investigator in the paliperidone palmitate clinical trials.
"Inconsistent compliance with medications is arguably one of the single greatest impediments to managing the symptoms of schizophrenia and delaying the time to relapse," he said in a prepared statement.
READ MORE @ MEDPAGE TODAY
The long-acting drug is approved for both acute and maintenance treatment.
The parent drug -- paliperidone in a once-daily tablet -- is an active metabolite of an old pharmaceutical, the atypical antipsychotic risperidone (Risperdal). (See Invega (paliperidone), Son of Risperdal (risperidone), Wins FDA Okay for Schizophrenia)
Researchers see once-monthly dosing as a potential solution for the medication adherence problems common in schizophrenia, noted Henry A. Nasrallah, MD, of the University of Cincinnati, an investigator in the paliperidone palmitate clinical trials.
"Inconsistent compliance with medications is arguably one of the single greatest impediments to managing the symptoms of schizophrenia and delaying the time to relapse," he said in a prepared statement.
READ MORE @ MEDPAGE TODAY
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