CORRECTING and REPLACING Forest Laboratories, Inc. Announces Commercial ...

NEW YORK--( BUSINESS WIRE )--Please replace the release with the following corrected version due to multiple revisions.

The corrected release reads:

FOREST LABORATORIES, INC. ANNOUNCES COMMERCIAL AVAILABILITY OF VIIBRYD(TM) IN PHARMACIES

New Treatment for Major Depressive Disorder in Adults Now Available in Pharmacies

Forest Laboratories, Inc. (NYSE: FRX) announced today that VIIBRYD(TM) (vilazodone HCl) tablets is now available at pharmacies throughout the United States. VIIBRYD is a prescription medicine indicated for the treatment of adults with Major Depressive Disorder (MDD).

The U.S. Food and Drug Administration (FDA) approved VIIBRYD as a new molecular entity on January 21, 2011, making it the first and only approved selective serotonin reuptake inhibitor (SSRI) and 5HT receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

The efficacy of VIIBRYD as a treatment for MDD was established in two 8-week, multicenter, randomized, double-blind, placebo-controlled studies of 861 adult patients, 436 of whom received VIIBRYD, and who met the criteria for MDD. In these studies, patients were titrated over two weeks to a dose of 40 mg of VIIBRYD once daily with food. VIIBRYD was superior to placebo in the improvement of depressive symptoms as measured by the mean change from baseline (95% confidence interval) to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score of -3.2 (-5.2, -1.3) and -2.5 (-4.4, -0.6) for Studies 1 and 2, respectively.

VIIBRYD was demonstrated to be safe in clinical studies. In the placebo-controlled, pivotal studies, the most commonly observed adverse reactions in VIIBRYD-treated patients were diarrhea, nausea, vomiting and insomnia. No single adverse event led to discontinuation of treatment in greater than 1% of patients. Overall, 7.1% of the patients who received VIIBRYD discontinued treatment due to an adverse reaction, compared with 3.2% of placebo-treated patients. VIIBRYD has not been associated with any clinically important changes in laboratory test parameters including liver function tests, ECG including QT interval or vital signs. In addition, VIIBRYD had no effect on body weight as measured by mean change from baseline in the 8-week studies. Among the common adverse reactions (≥2%) related to sexual function with VIIBRYD compared to placebo were decreased libido (4% vs <1%), abnormal orgasm (3% vs 0%), delayed ejaculation (2% vs 0%, males only) and erectile dysfunction (2% vs 1%, males only).

The bipolar bandwagon?

Once again, I am utterly behind the times. I was only recently made aware of the mid-April revelation that Catherine Zeta-Jones revealed she had been diagnosed Bipolar II. Apparently Carrie Fisher also struggles with the illness. Another article said that Mel Gibson and Charlie Sheen have also talked about having the disorder.

Some joke that it’s a mental illness bandwagon everyone is jumping on. Frankly, before I was diagnosed, I would probably agree. I think both Sheen and Gibson are poster children for regular bipolar disorder. From what I’ve read about Angelina Jolie (yes, I picked up a guilty pleasure book once about her and Brad Pitt, so sue me), I’m pretty convinced she’s at least Bipolar II. Probably just straight up Bipolar with a good handle on masking it.

But three years ago, I was diagnosed with Bipolar II disorder. There are a lot of variables that make it harder to diagnose, which means it can go untreated. People might just ascribe it to artistic temperament, flakiness, or regular depression. As it becomes better understood, there will be an inevitable rash of diagnoses — just like with ADD. Unfortunately, that also causes people to become skeptical of it.

Also, let’s be honest here: “Bipolar” sounds a helluva lot scarier than normal depression. The latter is finally making some headway, and is starting to gain acceptance in society at large. But “bipolar” just conjures up images of crazy people doing erratic, ridiculous things.

Who would want to be associated with that?

So it often takes one or two (preferably famous) people admitting to the disease before others will also talk about it. Because there is something to the whole “safety in numbers” deal. And in Hollywood, it can be career ending to admit to something as scary-sounding as bipolar disorder.

So good for Zeta-Jones and Fisher. Gibson and Sheen, well I think maybe they should do a little less talking about it and a little more medicating — of the non- pill/liquor variety. Sheen in particular, from what little I’ve read, seems to treat it all as a joke. A “Well, sure I’m bipolar but I’m not like those people” kind of attitude.