PharmaDirections congratulates Orexigen Therapeutics on achieving FDA Advisory Board approval for their anti-obesity drug Contrave™. PharmaDirections is proud to have been Orexigen’s pharmaceutical development partner and to have developed and produced the first Contrave™ product to undergo full clinical development.
Orexigen achieved a major milestone for the two out of three Americans who are overweight or obese. There has not been a new weight loss medication introduced in the last 10 years and several drugs that were on the market have been withdrawn due to safety concerns. Two other drug makers submitted NDA applications for anti-obesity treatments earlier this year, but the same advisory panel that approved Contrave™ rejected their applications because of side effect concerns. The difficulties faced by others in gaining approval further demonstrate the significance of this achievement.
Contrave™ combines the anti-craving drug naltrexone with the antidepressant bupropion in a single tablet. The combination boosts metabolism while curbing appetite and cravings. PharmaDirections was in charge of developing innovative formulations resulting in a tri-layer tablet that allowed a controlled release of naltrexone independent from the controlled release of bupropion. PharmaDirections also developed intellectual property claims for the reduction of side effects and around unique pharmacokinetic parameters. Using pharmacokinetic modeling they found pharmacokinetic/pharmacodynamic relationships that allowed the reduction of the naltrexone dose from 50 mgs in the single use tablet to 8 mgs in the combination product.
PharmaDirections was also in charge of unique manufacturing solutions to initiate Phase 3 clinical trials for Contrave™. They used the proprietary Instant GMP™ virtual manufacturing systems to significantly reduce the lead time for production and to get Phase 3 trials started faster than possible with traditional manufacturing options. The result was 3 months from developing a formulation to getting product shipped to the clinic.
According to data from BioMedTracker, Contrave™ sales could reach $1.2 billion by 2018. That figure would make it the top player in a U.S. weight-loss drug market. We wish Orexigen all the best in their quest to provide an innovative solution to a difficult medical challenge.
About Instant GMP™
Instant GMP™ allows PharmaDirections to manufacture clinical trial materials using variable and cost-efficient resources. It is a suite of virtual GMP manufacturing systems that takes full advantage of internet based quality systems and Part 11 compliant applications to streamline the entire end to end process of producing clinical trial materials. The system simplifies documentation and approval procedures to reduce production lead times. It allows PharmaDirections to be flexible when clinical protocols change and quickly adapt to updated study designs that impact CTM manufacturing. The suite is ideally suited to the global market place since manufacturing can be done in any geographical region while all data and intellectual property is securely stored by servers in the US.
Source: PharmaDirections