Acura Pharmaceuticals Inc. has announced plans for a new clinical study involving their drug candidate LTX-03, a formulation combining hydrocodone bitartrate and acetaminophen. This decision follows a recent meeting with the US Food and Drug Administration (FDA), where further development requirements were discussed. The study, designated AP-LTX-310, will compare a single tablet dose of LTX-03 to a single FDA Reference Standard drug under fed and fasted conditions. LTX-03 utilizes Acura's LIMITx technology, designed to lower peak drug blood concentrations as additional tablets are consumed. FDA has agreed to potentially describe the unique pharmacokinetic characteristics of LTX-03 in its labeling, subject to a New Drug Application (NDA) review. Acura Pharmaceuticals is also considering plans to support lower dosage strengths of LTX-03 for the NDA submission or after approval.
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