$ACUR: Acura Pharma announces the FDA has provided
Post# of 22755
Posted On: 12/15/2016 10:35:05 AM
$ACUR: Acura Pharma announces the FDA has provided it with advice on the continued development of LTX-04; co intends to advance new formulations of LTX-04 tablets to a second pharmacokinetic study which is expected to start in late first quarter of 2017
The FDA confirmed the Company's stated direction to reformulate LTX-04 to provide greater levels of drug in the blood stream following an intended 1 or 2 tablet dose, noting a scientific bridge of bioequivalence to DILAUDID will support a finding of safety and efficacy. In Study AP-LTX-400 (Study 400), the LTX-04 tablets delivered approximately 50% of the maximum drug concentration in the blood stream (Cmax) following intended 1 and 2 tablet doses compared to DILAUDID.In Study 400, the Company observed an average 20% reduction in maximum drug concentration in the blood stream under Oral ETA conditions, when 3, 4, 6, and 8 tablets were ingested. The FDA recommended the Company, in the future, identify studies to measure the clinical impact on abuser behavior and overdose outcomes (such as drug liking and respiratory depression) associated with the LTX-04 reductions in Cmax. The FDA did not disagree with the Company's approach to measuring the reduction in Cmax but did note modifications made to the data to adjust Cmax based on the 1 and 2 tablet dose make it difficult to draw conclusions about individual patients or patient subpopulations.In its subject level analysis of Study 400, the Company identified a subpopulation (53% of study subjects) that absorbed the drug in DILAUDID faster and to a greater extent and this "faster" subpopulation had more profound reductions in Cmax when taking LTX-04, including a 38% average reduction in Cmax with a 66% maximum reduction observed in 12% of the subpopulation. The FDA noted that to label a product for a particular patient subpopulation, prescribers should be able to understand that only a subset of their patients may benefit from use of the product.The FDA's advice also identified longer term studies necessary for submitting a New Drug Application for LTX-04, including in vitro extraction studies, drug interaction studies, additional pharmacokinetic studies assessing the impact of food and beverages, and, if abuse-deterrent labeling is requested, a category 3 abuse liability study.Acura intends to advance new formulations of LTX-04 tablets to a second pharmacokinetic study which is expected to start in late first quarter of 2017 after Acura addresses certain formulation stability issues.
The FDA confirmed the Company's stated direction to reformulate LTX-04 to provide greater levels of drug in the blood stream following an intended 1 or 2 tablet dose, noting a scientific bridge of bioequivalence to DILAUDID will support a finding of safety and efficacy. In Study AP-LTX-400 (Study 400), the LTX-04 tablets delivered approximately 50% of the maximum drug concentration in the blood stream (Cmax) following intended 1 and 2 tablet doses compared to DILAUDID.In Study 400, the Company observed an average 20% reduction in maximum drug concentration in the blood stream under Oral ETA conditions, when 3, 4, 6, and 8 tablets were ingested. The FDA recommended the Company, in the future, identify studies to measure the clinical impact on abuser behavior and overdose outcomes (such as drug liking and respiratory depression) associated with the LTX-04 reductions in Cmax. The FDA did not disagree with the Company's approach to measuring the reduction in Cmax but did note modifications made to the data to adjust Cmax based on the 1 and 2 tablet dose make it difficult to draw conclusions about individual patients or patient subpopulations.In its subject level analysis of Study 400, the Company identified a subpopulation (53% of study subjects) that absorbed the drug in DILAUDID faster and to a greater extent and this "faster" subpopulation had more profound reductions in Cmax when taking LTX-04, including a 38% average reduction in Cmax with a 66% maximum reduction observed in 12% of the subpopulation. The FDA noted that to label a product for a particular patient subpopulation, prescribers should be able to understand that only a subset of their patients may benefit from use of the product.The FDA's advice also identified longer term studies necessary for submitting a New Drug Application for LTX-04, including in vitro extraction studies, drug interaction studies, additional pharmacokinetic studies assessing the impact of food and beverages, and, if abuse-deterrent labeling is requested, a category 3 abuse liability study.Acura intends to advance new formulations of LTX-04 tablets to a second pharmacokinetic study which is expected to start in late first quarter of 2017 after Acura addresses certain formulation stability issues.
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