Elite Pharmaceuticals (OTCQB:ELTP) reports positive topline results from a pivotal bioequivalence study of its generic version of OxyContin (extended release oxycodone hydrochloride), incorporating its ART abuse-deterrent technology.
The company plans to file a marketing application in the U.S. later this year.
ART is a multi-particulate capsule which contains the opioid in addition to naltrexone, an opioid antagonist. When taken as directed, the naltrexone passes through the body unreleased. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the opioid-related effects.
Elite Pharmaceuticals (OTCQB:ELTP) enters into a collaboration and license agreement with privately held SunGen Pharma, LLC to develop and commercialize four generic products.
Under the terms of the deal, the companies will share responsibilities and costs and the products will be jointly owned after regulatory approval. SunGen will have exclusive rights to market two of the products under its own label and Elite will have exclusive rights to market the other two under its label. Elite will manufacture all four on a "cost plus" basis. Financial terms are not disclosed.
The four products are not specifically identified, but two are CNS stimulants and two are beta blockers. According to IMS Health, the U.S. market for the four is more than $3B.
A 163-subject Phase 3 study evaluating Elite Pharmaceuticals' (OTCQB:ELTP +23.6%) lead abuse-deterrent opioid candidate, ELI-200, for the treatment of moderate-to-severe pain achieved its primary endpoint of a statistically significant reduction in pain following surgery versus placebo (p=0.001). The multicenter, randomized, multiple-dose, double-blind, placebo-controlled, parallel-group trial was conducted at five U.S. sites.
The company intends to file a New Drug Application (NDA) with the FDA by year end.
The company's abuse-deterrent technology, called ART, is a multi-particle capsule containing an opioid agonist (the pain killer) and the opioid antagonist naltrexone. When the product is used as directed, the naltrexone passes unreleased through the body. If the multi-particulate beads are crushed or dissolved, naltrexone is released which blocks opioid-related euphoria.
163 patients have been enrolled and dosed in a Phase 3 study assessing Elite Pharmaceuticals' (OTCQB:ELTP -0.8%) abuse-deterrent opioid, ELI-200, for the treatment of severe post-surgical pain. Top-line data are expected by year end.
ELI-200's abuse-deterrent technology, called ART, is a multi-particulate capsule that contains the opioid antagonist naltrexone. When taken as intended, the naltrexone passes through the body unreleased while the opioid agonist is released over time to relieve pain. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the opioid-associated euphoria.
The FDA accepts for review the New Drug Application (NDA) from Teva Pharmaceutical Industries (TEVA -0.6%) for CEP-33237, its hydrocodone bitartrate extended release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
The product is formulated with its proprietary abuse-deterrent technology, although it does not specify the nature of the technology or how it works. In an oral human abuse liability study (HAL) in nondependent recreational opioid users, the abuse potential of finely crushed CEP-33237 powder was significantly lower based on peak at-the-moment drug liking. An intranasal HAL study produced the same result.
Elite Pharmaceuticals (OTCQB:ELTP) plans to commence a Phase 3 study in late March evaluating its abuse-deterrent opioid product candidate, ELI-200. The company has submitted a study protocol to the FDA and expects to receive its comments by mid-March. Patient dosing should start shortly thereafter.
The multi-center, randomized, double-blind, placebo-controlled, parallel group clinical trial will assess the safety and efficacy of abuse-deterrent ELI-200 for the treatment of adult patients with moderate-to-severe pain following surgery. The study will enroll ~150 patients and will take ~eight weeks to complete.
Elite projects submitting a New Drug Application (NDA) in Q3 and achieving regulatory clearance by early 2016.
The company's abuse-deterrent technology is a multi-particulate capsule that contains an opioid agonist in addition to the opioid antagonist, naltrexone. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the effects of the opioid. The technology is the firm's top priority, expected to add considerably to its modest revenues to date. Fiscal Q3's top line was only $1.4M.
Elite Pharmaceuticals (ELTP +9.5%) settles its claims with Novel Laboratories and other parties regarding the termination of their Strategic Alliance Agreement. In addition, the parties paid Elite $5M for 9,800 shares of Novel Class A common stock. This resolves all disputes and claims between the parties and ends Elite's ownership in Novel.