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August 15, 2014
06:17 EDTACURAcura announces preliminary discussions held with FDA for acetaminophen tablet
Acura Pharmaceuticals announced preliminary discussions from a meeting held with the FDA regarding the development pathway for Acura's AVERSION hydrocodone with acetaminophen tablet development candidate, which is intended to provide abuse-deterrent features to address abuse by nasal snorting and injection. In a May 2014 letter to Acura, FDA questioned the relevance of abuse of hydrocodone with acetaminophen products by nasal snorting after reviewing clinical and epidemiology data submitted by Acura. The FDA continues to question the relevance of abuse of hydrocodone with acetaminophen products by the intranasal route of administration and suggested additional information may help better inform their decision. The FDA indicated in the discussions that Acura may conduct an additional nasal abuse liability study for its AVERSION hydrocodone with acetaminophen product candidate, the outcomes of which may help inform the relevance decision as well as establish a reduction in drug liking, which was not statistically significant in an earlier Acura study. The FDA requested further time to deliberate on the issues discussed during the meeting before issuing final meeting minutes. Acura intends to review its clinical data from Study AP-ADF-301 to determine whether to proceed with an additional clinical study for its AVERSION hydrocodone with acetaminophen product candidate and to further evaluate options to address the issues of intranasal abuse and drug liking raised by the FDA.
News For ACUR From The Last 14 Days
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February 1, 2016
16:13 EDTACURAcura Pharma says clinical testing on LTX-04 to commence in Q1
Acura Pharmaceuticals announced that clinical testing of its lead LIMITX oral abuse deterrent drug candidate using the opioid hydromorphone HCl is allowed to proceed under an Investigational New Drug Application, or IND, the company filed with the FDA on December 30, 2015. LIMITX is designed to retard the release of the product's active ingredient as more and more tablets are orally consumed thereby limiting peak blood concentrations of the opioid. The company is in the process of manufacturing clinical trial materials and expects to commence enrollment in the first clinical study of LTX-04, Study AP-LTX-400, later in Q1. Study AP-LTX-400, will be a Phase 1 exploratory pharmacokinetic study to evaluate the plasma absorption of hydromorphone from orally administered tablets in the fasted state. Study AP-LTX-400 will target to complete approximately 48 healthy subjects in two separate cohorts, with 24 subjects in each cohort. For safety, all subjects will receive a naltrexone block prior to and during dosing to blunt any serious adverse effects that may result from the doses of hydromorphone. Subjects in Cohort 1 will be further randomized into three dosage groups taking either one, two or three 2mg hydromorphone tablets. Each Cohort 1 subject will take two different test formulations of LTX-04 and DILAUDID brand of hydromorphone HCl. The objective of Cohort 1 will be to determine if the LTX- 04 test products are delivering the appropriate amount of hydromorphone into the blood stream to treat pain. Additionally, Cohort 1 may begin assessing the extent that the release of hydromorphone active ingredient from the LTX-04 tablets is retarded as the dose level increases. Following the results of Cohort 1, Cohort 2 subjects will be randomized into three dosage groups taking four, six or eight 2mg hydromorphone tablets. Each Cohort 2 subject will take one test formulation of LTX-04 selected based on the results of Cohort 1 and DILAUDID. The objective of Cohort 2 will be to further explore the extent the release of hydromorphone active ingredient from LTX-04 tablets is retarded as the dose level increases to abusive levels. A safety assessment of LTX-04 will be made from both study cohorts. Acura expects topline study results from Study AP-LTX-400 to be available in the first half of 2016.

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