Acura Pharmaceuticals, Inc. (NASDAQ:ACUR) has reported successful results from the second regiment of the AP-LTX-400 clinical trials.
The firm announced that the ingestion of four, six and eight tablets slowed down the release of the active opioid component. The latest results are also similar to the successful results that the firm obtained from the first regiment study 400. This means that the AP-LTX-400 possess oral abuse deterrent abilities from a dose of three LTX-04P tablets. This means that the company will have to continue carrying out research and development on LTX-04P so that it can reduce the number of pills to one or two tablets. It therefore has to create the right formula to deliver the right amount of active ingredients required by the patients.
Acura Pharmaceuticals expects to commence clinical trials for the new LTX-04 mix in the fourth quarter this year after finalizing the reformulation work which is currently ongoing. Additionally the company has to make sure that it consults with the Food and Drug Administration Agency in the US concerning the results of the Study 400.
The company used the LIMITX technology in the recently concluded trials. Thepatented technology neutralizes the acidity in the stomach as the patient ingests more pills. It also relies on the acid in the stomach to help activate the release of various active components found in the micro-particles in the pills. The second group trials of the Study 400 analyzed the performance of the LTX-04P in the 4, 6 and 8 regiment groups and compared it against DILAUDID.
The first cohort trials analyzed the Study 400 regiment subgroups that took 1, 2 and three tablets. The clinical trials analyzed the extent and rate of absorption of the drug into the blood with the highest level of concentration. Study 400 revealed that the relative Cmax when patients ingested 3 or more pills dropped by 22%. The researchers reported that the patients in the drug trials did not register any adverse reactions to the treatment.