- Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee Review
Oct 27, 2005 - Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) and Shire Pharmaceuticals Group plc (LSE: SHP) (NASDAQ: SHPGY) (TSX: SHQ) announced today that the amended New Drug Application (NDA) for MTS (methylphenidate transdermal system) will be reviewed by the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee at their scheduled open session on December 2, 2005. MTS is a transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. The NDA amendment has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 28, 2005.
- About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a developer of advanced transdermal drug delivery technologies and prescription transdermal products. Noven's prescription patches are sold in over 30 countries, and a range of new patches are being developed in collaboration with Shire Pharmaceuticals Group plc, Novartis Pharma AG, P&G Pharmaceuticals, Endo Pharmaceuticals Inc. and others. Noven is committed to expanding the universe of available transdermal therapies for the benefit of patients, partners and shareholders. See www.noven.com for additional information.
- About Shire
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), renal diseases and human genetic therapies. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US. For further information on Shire, please visit the Company's website: www.shire.com.
- About MTS and Methylphenidate
In pivotal clinical studies managed by Shire, MTS was generally well tolerated and adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate. The most common adverse events reported by patients who received MTS in clinical trials were: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite, affect lability, insomnia, tic, and nasal congestion.
Methylphenidate should not be administered to patients with: glaucoma; tics, Tourette's syndrome or a family history of Tourette's syndrome; current or recent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse of methylphenidate may lead to dependence and careful supervision following withdrawal from abuse is warranted. Methylphenidate should not be given to patients with a history of drug dependence or alcoholism. Methylphenidate should not be used for the prevention or treatment of severe depression or normal fatigue states. Growth should be monitored in patients treated with methylphenidate. Use with caution in patients with psychosis, history of seizures or EEG abnormalities, hypertension, a history of drug dependence or alcoholism. Rare cases of visual disturbances have been reported with methylphenidate use. Hematologic monitoring is advised during prolonged therapy.
The content presented for background information and is based on a press release. The medication discussed is not yet available and has not been approved by the FDA..
Contact Noven Pharmaceuticals, Inc. Joseph C. Jones, 305-253-1916