Alkermes, Inc. (NASDAQ: ALKS) today announced the initiation of a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers. Preclinical studies have shown ALKS 37 targets the gastrointestinal tract following oral administration, with limited systemic exposure. ALKS 37 is a component of ALKS 36, a combination drug candidate for the treatment of pain without the side effects of constipation.
According to IMS Health, over 200 million prescriptions were written for opioids in 2007 in the United States. Many studies indicate that a high percentage of patients receiving opioids are likely to experience side effects affecting gastrointestinal motility.
"While opioids are a common and effective treatment for managing chronic pain, the side effects of these medications can be debilitating and may diminish patient adherence to pain medication," stated Daniel Deaver, Ph.D., Vice President, Non-Clinical Development of Alkermes. "We are excited to bring forward ALKS 37 into the clinic as it has the potential to enable the use of pain medications without inhibiting gastrointestinal motility."
“Our unique understanding of opioid biology and pharmacology allowed us to take a very innovative approach to the development of a GI-targeted therapy such as ALKS 37,” said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. “Today’s announcement is a testament to our advancing proprietary pipeline.”
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