Paxil CR Relieves PMDD Symptoms in Clinical Trials

The tolerability and efficacy of Paxil CR(TM) (paroxetine HCl) Controlled-Release for the treatment of PMDD was established in placebo-controlled studies. In these studies, the lowest dose of Paxil CR, 12.5 mg per day, was significantly better than placebo in reducing the emotional and physical symptoms of PMDD. Similar results were seen with the 25 mg per day dose. Patients reported significant improvements in social functioning. Compared with women on placebo, patients taking Paxil CR reported fewer symptoms that interfered with regular daily activities.

Controlled-Release Paxil Tablets

Paxil CR (paroxetine HCl) offers the proven efficacy of paroxetine in a Geomatrix oral drug delivery system. The tablet is a multi-layered formulation that controls dissolution and absorption of the drug in the body. Paxil CR offers flexible dosing, and is available in three dosing strengths: 12.5 mg, 25 mg, and 37.5 mg. Geomatrix technology is licensed from SkyePharma PLC. Paxil CR is under review at FDA for social anxiety disorder and for the intermittent dosing for PMDD. For more information on Paxil CR log on to www.paxilcr.com.

About Paxil CR

Most common adverse events (incidence of 5% or greater and incidence for Paxil CR and at least twice that for placebo) in studies for major depressive disorder, panic disorder and PMDD include infection, trauma, nausea, diarrhea, dry mouth, constipation, decreased appetite, somnolence, dizziness, decreased libido, tremor, yawn, sweating, abnormal vision, asthenia, insomnia, abnormal ejaculation, female genital disorders and impotence. Patients should not be abruptly discontinued from antidepressant medication, including Paxil CR. Concomitant use of Paxil CR in patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated.

Source: GlaxoSmithKline