Feeds:
Posts
Comments

Archive for the ‘Meds’ Category

The AP(10/29, http://tinyurl.com/latuda1) reports The Food and Drug Administration approved a new drug from Sunovion Pharmaceuticals to treat adults with schizophrenia.   Schizohrenia affects about 1 percent of the U.S. population, causing hallucinations, paranoia and delusions.  The FDA approved Sunovion’s drug Latuda based on four studies that showed patients taking the drug had fewer schizophrenia symptoms than patients taking a placebo pill.  Latuda is part of the atypical antipsychotics drug class, which also includes Eli Lilly & Co.’s Zyprexa, Johnson & Johnson’s Risperdal and AstraZeneca’s Seroquel.  Those drugs were the top-selling group of prescription drugs in the U.S. last year, with combined sales of $14.6 billion.  Sunovion Pharmaceuticals Inc. is based in Fort Lee, N.J. and is the U.S. subsidiary of Japanese drugmaker Dainippon Sumitomo Pharma Co.

“Latuda is an oral, once-daily atypical antipsychotic, offering a first-line treatment option for patients with schizophrenia and is expected to be available in the US during the first quarter of 2011,” Marlborough-based Sunovion said.  Sunovion recently changed its name from Sepracor, a company known for its Lunesta sleep aid. A year ago, Sepracor was acquired by Dainippon Sumitomo Pharma Co., a Japanese drug maker.

Read Full Post »

HealthDay (6/29, http://tinyurl.com/generic-eff-xr) reported the first generic version of Effexor extended release  (XR) capsules (venlafaxine hydrochloride) to treat major depressive disorder has been approved by the U.S. Food and Drug Administration.  Teva said it will start shipping its version of Effexor, or venlafaxine, on July 1st, 2020. The Israeli company originally sought approval for its generic in 2006, but as part of a patent settlement with Wyeth  it agreed not to sell its version until July 1, 2010. Pfizer acquired Wyeth last year.  As the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.  Teva said annual U.S. sales of Effexor XR are around $2.75 billion.

Read Full Post »

According to a study done by Blier et al published in the American Journal of Psychiatry (http://tinyurl.com/mirtazapine-combo) “the use of antidepressant combinations from treatment initiation may double the likelihood of remission compared with use of a single medication”. Various classes of antidepressant medications generally induce remission of major depressive disorder in only about one-third of patients. In a previous study using  mirtazapine or paroxetine alone or in combination from treatment initiation, the rate of patients who remitted within a 6-week period was twice that of patients using either drug alone. In the current study “remission rates (defined as a HAM-D score of 7 or less) were 25% for fluoxetine, 52% for mirtazapine plus fluoxetine, 58% for mirtazapine plus venlafaxine, and 46% for mirtazapine plus bupropion”.  “The study results, which add to a growing body of evidence, suggest that use of antidepressant combinations from treatment initiation may double the likelihood of remission compared with use of a single medication”.

Read Full Post »

The AP (http://tinyurl.com/long-lasting-zyprexa 12/15) reports Drugmaker Eli Lilly & Co said regulators have approved a longer-lasting version of its top-selling drug, the anti-psychotic Zyprexa.  The Food and Drug Administration approved Zyprexa Relprevv, an injection that can last up to four weeks, for the treatment of schizophrenia in adults.  Patients on Zyprexa currently take a pill daily. Lilly also makes a fast-acting injection of the drug that can be absorbed by the body in a few hours to treat agitation.  For the new version, patients will visit their doctors every two or four weeks to receive the injection, spokeswoman Janell Smith said.  She said the longer-lasting version makes it easier for patients to stay on the medication, and it allows doctors to track whether they’re doing that since they have to make office visits for the injections. 

Read Full Post »

The AP ( 12/4 http://tinyurl.com/seroquel-xr-mdd) reported Pharmaceutical company AstraZeneca PLC has won U.S. approval for use of its schizophrenia drug Seroquel XR as an add-on treament for major depressive disorder.  But the London-based company said that the U.S. Food and Drug Administration has asked for more information before allowing the drug’s use as a single agent to treat major depressive disorder, or MDD.  Seroquel XR is an extended-release version of AstraZeneca’s schizophrenia medication Seroquel, a major seller for the company. It is already approved for bipolar disorder and schizophrenia.  AstraZeneca said it is evaluating the FDA’s request.  “AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course,” it said in a statement.

Read Full Post »

The AP (http://tinyurl.com/abilify-for-autism 11/21) reported that the FDA “has approved top-selling Abilify [aripiprazole] as a treatment for autism-related irritability in children from the ages of six 17…Bristol-Myers Squibb Co. said Friday.” The agency’s “latest approval allows the” medication “to be used to treat symptoms associated with autism, such as aggression toward others, deliberate infliction of self-injury, tempter tantrums, and moodiness.” Bristol-Myers and Otsuka Pharmaceutical Co., collaborators on the development and distribution of Abilify in the US and Europe, “said in a statement that it was intended to be used as part of a more comprehensive treatment program that includes educational, psychological, and social aspects.”

Read Full Post »

lamictalDow Jones Newswire ( 11/6  http://tinyurl.com/generic-lamictal) reports, “Aurobindo Pharma Ltd. said Friday it has received the final approval from the US Food and Drug Administration for selling a generic version of the epilepsy” medication lamotrigine [Lamictal]. The FDA approval “is for 5-milligram and 25-mg tablets.” GlaxoSmithKline manufactures the brand name version of the medication.

Read Full Post »

topamaxThe AP (10/15) reported, “Mylan Inc. said Thursday it received regulatory approval for its version of Johnson & Johnson’s epilepsy drug Topamax [topiramate], and began shipping” the “15 milligram and 25 milligram topiramate sprinkle capsules.” The patents “on Topamax expired in March,” and the AP notes that “Teva Pharmaceutical Industries Ltd. also markets a generic version of the drug.”

Read Full Post »

moneyBBC News (10/6, Robert) reported that researchers at the University of London “are resorting to paying some psychiatric patients in the hope it will make them take their medication.” During “a trial, 68 patients with bipolar disorder or schizophrenia will get £15 [$23.81] for every jab of” an anti-psychotic, “earning them a possible £720 [$1,143] in a year,” while 68 other patients will receive “usual care.” According to study leader Professor Stefan Priebe, “bribery may be an option” after “all other attempts to achieve adherence” to medication regimens “have failed.” Priebe “expects that not only will patients be happy to trade an injection for cash, but that the ‘money for medication’ scheme should pay for itself, with the financial costs more than off-set by the savings made in reduced hospital admissions.”

Read Full Post »

sinemetThe AP (9/30) reported, “Mylan, Inc. said Wednesday it started selling a generic version of Bristol-Myers Squibb Co.’s Parkinson’s disease” medication Sinemet. The company received FDA approval for three doses of the generic version, which contains the medications “levodopa and carbidopa.”

Read Full Post »

Older Posts »