Micropump for Narcotic/Opioid Analgesics Abuse Resistance
Opioid analgesics are used to treat patient suffering from severe and chronic pain. The market for opioid drugs in the seven major markets (USA, Japan, and 5 European countries) was estimated to exceed $7.4 billion in 2010, dominated by oxycodone molecule. It is forecasted to reach $7.9 billion by 2012.
A major problem faced by the industry is the growing abuse and misuse of its controlled-release drugs by drug abusers, who extract the opioids from the drugs and achieve their immediate release. The proportion of narcotic/opioid analgesics abuse associated with emergency room admissions has more than tripled, from 6.8% in 1998 to 26.5% in 2008. Narcotic/opioid analgesics abuse continues to increase as current products remain easy to abuse.
Trigger Lock successfully addresses the issue of narcotic/opioid analgesics tampering:
- Micropump particles cannot be crushed to extract the narcotic/opioid analgesics;
- Prevent misuse of scheduled drugs such as narcotic/opioid analgesics;
- Additional modifications tailored to prevent other less publicized methods of foiling controlled release systems;
- Provides either bioequivalent or improved pharmacokinetics to marketed narcotic/opioid analgesics; and,
- May be applied to novel, already-marketed, or off-patent narcotic/opioids.
A Trigger Lock application is in co-development with a major pain therapy company.
On April 28, 2011, Flamel Technologies announced a license agreement with a leading specialty pharmaceutical company for the development and commercialization of two molecules for pain indications.
Flamel will receive an upfront license fee of $3 million, as well as milestones, and mid-single digit royalties upon eventual sale of the respective products.
FDA plans to implement a Risk Evaluation and Mitigation Strategy (REMS) requirement for all extended-release opioid analgesics. The FDA’s move to restrict prescribing extended-release opioid analgesics should benefit tamper-resistant formulations such as Trigger Lock-based formulations of opioids.