Alkermes Starts Phase 1 Clinical Study Of New Pain Relief Drug

Alkermes announced yesterday that it is initiating a phase 1 clinical study of a new, proprietary, oral drug candidate, ALKS 7106, for the treatment of pain. ALKS 7106 is an investigative opioid analgesic drug which is designed to treat severe pain while minimizing the risk of abuse and addiction.

The phase 1 clinical trial will be a randomized, double-blind, placebo-controlled study which will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 in approximately 80 healthy, male adults. This study will be a single-ascending-dose, multi-cohort, four-week study of ALKS 7106 administered orally. Results from this phase 1 study are expected in the first half of 2015.

“Pain relievers are some of the most prescribed medicines in America, and there is a significant need for new opioid treatment options for pain that can provide analgesic effect with lower abuse potential and risk of overdose, compared to conventional opioid pain medications,” said Elliot Ehrich, M.D., CMO of Alkermes. “Based on preclinical studies, ALKS 7106 appears to have intrinsic properties that may address these serious risks while maintaining analgesic effect, and we look forward to determining whether these findings are also observed in the clinic.”

ALKS 7106, a novel, small-molecule drug candidate, is a potent opioid modulator. Opioid analgesics work by binding to opioid receptors, which are present in the central and peripheral nervous system. Morphine, its analogues, and synthetic derivatives are some of the common opioid analgesics, also known as narcotic analgesics. These drugs are used to treat severe pain, and unfortunately have the tendency to cause tolerance and dependence in patients. Abuse and overdose death are two of the main liabilities of using these drugs. According to Alkermes, ALKS 7106 possesses several attributes that can help reduce dependence in those taking that drug, including its intrinsic mechanism of action in the brain, rather than through the use of abuse-deterrent technologies or formulations.

In preclinical models, the highly potent ALKS 7106 demonstrated similar efficacy to morphine, even at a 30-fold lower dose. The drug candidate was also tested at doses far in excess of those required for analgesic action and was found to be well tolerated. Additional preclinical data for ALKS 7106 demonstrated a ceiling effect on neurotransmitter release over a broad concentration range, suggesting low potential for abuse and overdose death.

This announcement is the latest in an eventful month for the company. Alkermes yesterday announced its submission of a New Drug Application (NDA) to the U.S. FDA for its long-acting injectable schizophrenia drug, aripiprazole lauroxil. Recently, the company also started another round of Phase 3 clinical trials on its other major drug candidate, ALKS 5461, for the treatment of major depressive disorder (MDD).