Oral Palonosetron was approved in EU
The second generation 5-HT3 Receptor Antagonist Palonosetron, already approved as an Intravenous Solution Formulation in more than 60 countries worldwide including US, EU and Japan, obtains the European Marketing Authorization for 0.5 mg Oral Capsules.
Palonosetron 0.5 mg soft gelatine capsule oral formulation has been approved by the EMA (European Medicine Agency) for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy (MEC) in adults. The European Marketing Authorization for the oral formulation of palonosetron, the second generation 5-HT3 receptor antagonist licensed worldwide by the Swiss pharmaceutical group Helsinn, follows the approval obtained in August 2008 in the USA.
Palonosetron (palonosetron hydrochloride) is a second generation 5-HT3 Receptor Antagonist, developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer, with a long half-life of 40 hours and at least 30 times higher receptor binding affinity than currently available compounds.
Palonosetron demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV. The product has shown to be effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapy (MEC). A single intravenous dose of palonosetron provides better protection from CINV than first-generation 5-HT3 receptor antagonists throughout a 5-day post-chemotherapy period.
Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions in CINV trials with palonosetron were headache (9 percent) and constipation (5 percent), and they were similar to the comparators. Palonosetron has been developed by the Helsinn Group in Switzerland and today it is marketed as Aloxi(R), Onicit(R), and Paloxi(R) in more than 50 countries world-wide. Palonosetron, marketed as Aloxi(R), is the leading brand in the USA within the CINV Day of Chemo segment, and it is steadily growing in the European markets.
