GlaxoSmithKline receives decision from US FDA on Requip® XL™
GlaxoSmithKline (NYSE:GSK) today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the New Drug Application for Requip® (ropinirole) XL™ Extended-Release Tablets for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.
This decision does not affect the immediate-release formulation of Requip® (ropinirole hydrochloride) Tablets, which is dosed three times a day and remains an important treatment for patients who suffer from idiopathic Parkinson’s disease.
Requip XL is an investigational extended-release, once-daily formulation that uses SkyePharma PLC’s (LSE: SKP) patented GEOMATRIX™ technology. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward.
About Requip Tablets (Immediate-Release Formulation)
The currently marketed formulation of Requip Tablets is indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson’s disease and is administered three times a day. Prescription Requip is not for everyone. Requip may cause patients to fall asleep or feel sleepy during normal activities such as driving; or to faint or feel dizzy, nauseated, or sweaty when they stand up. Patients should tell their doctor if they experience these problems or if they drink alcohol or are taking other medicines that make them drowsy. Patients should also tell their doctor if they experience new or increased gambling, sexual, or other intense urges while taking Requip. Hallucinations may occur at anytime during treatment. Requip may potentiate the side effects of L-dopa. Side effects include nausea, dizziness, drowsiness or sleepiness, headache, and dyskinesia (uncontrolled movements). Most patients were not bothered enough to stop taking Requip. This is not a complete list of side effects and should not take the place of discussions with patients’ healthcare providers. Their doctor or pharmacist can give patients a more complete list of side effects. Patients should talk to their doctor about any side effects they may have.
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The company has 11 approved products in the areas of oral, inhalation and topical delivery. The Group’s products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.
Requip was developed and is marketed by GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies. For detailed company information, see GlaxoSmithKline’s website: www.gsk.com.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group’s operations are described under ’Risk Factors’ in the ’Business Review’ in the company’s Annual Report on Form 20-F for 2006.
This news content was configured by WebWire editorial staff. Linking is permitted.
News Release Distribution and Press Release Distribution Services Provided by WebWire.