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CP216 is a long-acting injectable (LAI) formulation of naloxone, a small molecule opioid antagonist, developed by Consegna Pharma. It is designed to provide sustained release of naloxone over a 12 to 24-hour period to reverse or prevent opioid-induced respiratory depression. The drug acts as a competitive antagonist primarily at the mu-opioid receptor (MOR). CP216 is being developed via the FDA's 505(b)(2) regulatory pathway, which allows for the approval of new formulations of previously approved drugs. It is currently in the preclinical stage for the treatment of opioid abuse and overdose reversal.
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