Novartis announced that Fanapt (iloperidone) tablets are now available for use across the US for the acute treatment of schizophrenia in adults. Fanapt is a twice-daily, oral antipsychotic, approved by the US Food and Drug Administration (FDA) in May 2009.
The most common adverse drug reactions were dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight gain. In clinical trials, discontinuation rates due to side effects for patients on Fanapt and on placebo were similar. The incidence of akathisia, a feeling of inner restlessness often associated with other antipsychotics, was also shown to be similar between placebo and Fanapt - up to the maximum dose of 24 mg per day.
As many as 87% of patients taking Fanapt did not experience weight gain more than = 7% of body weight in clinical trials (88% for 10-16 mg doses; 82% for 20-24 mg doses, and 87% for all patients in the trials). Across all short- and long-term studies, the overall mean weight gain from baseline to end of the trial was 2.1 kg or less than five lbs.
Additionally, patients did not experience medically important changes in triglyceride and total cholesterol measurements. Fanapt also demonstrated a low incidence that was similar to placebo of the following extrapyramidal symptoms: parkinsonism, dystonia, dyskinesia and bradykinesia.
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Coming tommorow:
http://www.fda.gov/NewsEvents/ucm196493.htm
Webinar with Bloggers: New FDA Basics Web Resource
Do you and your readership have questions for the U.S. Food and Drug Administration (FDA)?
The FDA is pleased to announce the availability of a new Web resource, FDA Basics, which answers your questions and discusses other important public health topics in a useful and user-friendly format.
The tool answers questions such as:
• How and where do I find out if a drug is approved for use?
• When can I be sure that it is okay to buy previously recalled foods when they are back on the shelf?
• How do I know if I’m eligible to donate blood?
On Tuesday, January 12, at 4 p.m. ET, the FDA will host a webinar for bloggers interested in health-related topics. The featured speaker, Dr. Joshua Sharfstein, Principal Deputy Commissioner of the FDA, will showcase the new tool, discuss opportunities for the public to submit questions to FDA, and outline FDA efforts to enhance transparency across the agency. After the presentation, there will be an opportunity to ask questions or offer feedback.
To join:
Phone number: 888-950-5930
Passcode: 8068554
Web address: https://collaboration.fda.gov/fdabasics/
Please log-in as a guest.
We will be using the Twitter hashtag #FDABasics if you’d like to tweet about or follow the webinar on Twitter.
This webinar is open to the first 100 attendees who sign in to the meeting URL, and the phone portion is currently only available for participants in the U.S. We apologize for any inconvenience.
In order to view the webinar, Adobe Flash 8.0 or newer must be installed. Download the latest version of Adobe Flash: http://get.adobe.com/flashplayer/
Salmon
P.S.
Notice that FDA was so nice to inform people today about the webinar for tomorrow.
Great commitment to transparency.
Salmon
Mister blogger, do you start to promote products on your blog?
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