FDA Provides Advice on Further Development of LTX-04
PALATINE, IL--(Marketwired - December 14, 2016) - Acura Pharmaceuticals, Inc. (
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.
The patented LIMITx technology works by neutralizing stomach acid as increasing numbers of tablets are swallowed and relying on stomach acid to play a role in the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the tablets.
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 Company has already identified formulations that they believe will release drug faster at the 1 and 2 tablet dose. The Company intends to develop LTX-04 through proof of concept and then rapidly advance a formulation of a product with a greater prevalence of Oral ETA, such as immediate-release hydrocodone with acetaminophen.
LTX-04 was developed in part with a grant from the National Institute on Drug Abuse (NIDA). NIDA is not responsible for the results of any of the Company's research. The LTX-04 development program is also designated as Fast Track by the FDA for its potential to address an unmet medical need.
To further discuss these results Acura's management will host a conference call on Thursday, December 15, 2016 at 8:30 a.m. ET. To participate in the live conference call, please dial 888-632-3381 (U.S. and Canada) five to ten minutes prior to the start of the call. The participant passcode is 7979444. A replay of the call will be available beginning December 15, 2016 and ending on December 31, 2016. The replay participant code is 7979444.
About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX™, AVERSION® and IMPEDE® Technologies. LIMITX contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.
OXAYDO® (oxycodone HCl immediate-release tablets) which incorporates the AVERSION Technology, is FDA approved and marketed in the U.S. by our partner Egalet Corporation.
Acura markets NEXAFED® and NEXAFED® Sinus, which are pseudoephedrine containing products that utilize the IMPEDE Technology.
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DILAUDID is a trademark of Purdue Pharma L.P.
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