The Committee for Medicinal Products for Human Use (CHMP) of the EMEA delivered a positive opinion on two products: Archimedes Pharma’s PecFent® for breakthrough cancer pain and Brinavess, Merck & Co. and Cardiome’s therapy for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.
PecFent is an aqueous fentanyl citrate solution that uses Archimedes Pharma’s PecSys™ technology to allow fentanyl to be retained on the nasal mucosa. It is designed to produce rapid but controlled absorption into systemic circulation.
The positive opinion is based on the results of three Phase III studies including an active comparator study and a large long-term safety and acceptability study, Archimedes Pharma says. The program included over 650 patients and more than 100 investigational sites from 13 countries across four continents, including the U.S., U.K., Germany, France, Spain, and Italy.
Archimedes Pharma submitted an NDA for PecFent in August 2009. While the firm already has a marketing presence in Europe, it says that it is in the process of establishing commercial operations in the U.S.
CHMP’s positive opinion on Brinavess followed a review of data supporting the efficacy, safety, and tolerability profile of the treatment. The proposed indication is for the conversion of recent onset of AF to sinus rhythm in adult nonsurgery patients with atrial fibrillation of seven days or less and for adult postcardiac surgery patients with atrial fibrillation of three days or less.
If approved by the European Commission, Brinavess would be the first product in a new class of pharmacologic agents for cardioversion of atrial fibrillation to launch in the EU, according to Michael E. Mendelsohn, M.D., svp and head of cardiovascular research, Merck Research Laboratories.
The efficacy of Brinavess was evaluated at 90 minutes in a total of 390 hemodynamically stable adult patients with short duration AF (3 hours to 7 days). In the ACT I study, the drug cardioverted 51% of patients versus 4% of patients taking placebo. In ACT III, Brinavess cardioverted 51.2% of patients versus 3.6% of patients taking placebo. In responders the median time to conversion was 10 minutes from start of first infusion.
In the AVRO study, Brinavess was studied in 116 patients with AF (3 hrs to 48 hrs) versus 116 patients on amiodarone. The primary endpoint was the proportion of patients that achieved sinus rhythm within the first 90 minutes after initiating therapy. Treatment with Brinavess converted 51.7% of patients at 90 minutes versus 5.2% with amiodarone.