Acura Pharmaceuticals, Inc. (NASDAQ:ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of LTX-04, Acura’s hydromorphone HCl tablets utilizing its oral abuse deterrent LIMITX technology, for the management of pain in patients where an opioid analgesic is appropriate.
FDA’s Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy, including avoiding serious side effects of an available therapy.
A drug that receives Fast Track designation is eligible for, among other things, more frequent meetings and communications with the FDA and eligibility for accelerated approval and priority review, if relevant criteria are met. More frequent communication withFDA aids in the drug’s development plan, ensures collection of appropriate data needed to support drug approval, and providesFDA insight on clinical trial design and can assure that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. (Original Source)
Shares of Acura are up nearly 12% to $3.09 in after-hours trading. ACUR has a 1-year high of $6.75 and a 1-year low of $1.61. The stock’s 50-day moving average is $2.34 and its 200-day moving average is $2.31.
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. The company was founded in 1935 and is headquartered in Palatine, IL.