Acura Pharmaceuticals, Inc. (NASDAQ:ACUR) announced that the U.S. Food and Drug Administration (FDA) has provided the Company with advice on the continued development of its product candidate LTX-04 (hydromorphone HCI) which utilizes the Company’s novel LIMITx™ technology that is intended to provide safeguards against accidental overdose and oral excessive tablet abuse (Oral ETA).
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. (Original Source)
Shares of Acura are up 5.5% to $0.96 in after-hours trading. ACUR has a 1-year high of $3.52 and a 1-year low of $0.85. The stock’s 50-day moving average is $0.99 and its 200-day moving average is $1.58.
On the ratings front, Acura has been the subject of a number of recent research reports. In a report issued on October 18, Roth Capital analyst Michael Higgins reiterated a Buy rating on ACUR, with a price target of $6, which represents a potential upside of 512% from where the stock is currently trading. Separately, on the same day, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Higgins and Vernon Bernardino have a yearly average loss of -16.2% and -25.4% respectively. Higgins has a success rate of 31% and is ranked #4148 out of 4285 analysts, while Bernardino has a success rate of 18% and is ranked #4210.
Acura Pharmaceuticals, Inc. operates as a pharmaceutical company, which engages in the research, development and commercialization of products intended to address medication abuse and misuse, utilizing its proprietary aversion and impede technologies. It operates its business through the research, development and manufacture of innovative abuse deterrent, orally administered pharmaceutical products.