Canadians approve Paxil CR
The Therapeutic Products Directorate of Health Canada has approved Paxil CR (paroxetine hydrochloride Controlled Release tablets) for the treatment of depression, panic disorder and social anxiety disorder.
The Therapeutic Products Directorate of Health Canada has approved Paxil CR (paroxetine hydrochloride Controlled Release tablets) for the treatment of depression, panic disorder and social anxiety disorder.
Paxil CR, a selective serotonin reuptake inhibitor (SSRI) antidepressant, is already approved and marketed in the US for the treatment of major depressive disorder, panic disorder, premenstrual dysphoric disorder (PMDD) and, most recently, social anxiety disorder and is currently under FDA review for the intermittent treatment of PMDD. SkyePharma developed the controlled release formulation used in Paxil CR and receives a royalty on manufacturer GlaxoSmithKline's sales.
Michael Ashton, SkyePharma's chief executive officer, commented: 'We are pleased by this additional market opportunity for Paxil CR. Clinical studies have demonstrated that it significantly reduces the incidence of nausea, a common and troublesome side-effect in the first few weeks of treatment that results in poor compliance with many SSRI antidepressants. The low drop-out rate for patients on Paxil CR may increase the likelihood that patients will obtain the full therapeutic benefit. Paxil CR currently accounts for about one in twelve new US prescriptions for SSRI antidepressants and we hope for a similar level of success in Canada.'
To develop Paxil CR, GSK's antidepressant Paxil was reformulated using SkyePharma's Geomatrix oral drug delivery technology in which a multi-layered tablet controls the rate of dissolution and site of absorption of the drug in the body. GSK launched the product in the US in April 2002. It offers flexible dosing and in Canada will be available in two different dosing strengths: 12.5 mg and 25 mg.
About Geomatrix
Geomatrix controlled release systems control the amount, timing and location of drug release into the body. This is achieved by constructing a tablet with two basic components: a core containing the active drug or drugs, and one or two additional barrier layers that control the drug's diffusion out of the core. Tablets with a wide range of predictable and reproducible drug release profiles can be made by combining different chemical components in the core and barrier layers, each with a different rate of swelling, gelling and erosion.