Elite Pharmaceuticals (OTCMKTS:ELTP) On The Verge Of Major Developments

Elite Pharmaceuticals (OTCMKTS:ELTP) is one of the most exciting names on the OTC markets. The company is on the verge of same major developments that we think will propel shares higher in 2016. Matter of fact, ELTP could be one of the best performers on the bulletin boards if all goes according to plan.Elite Pharmaceuticals is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and a product under review pending approval by the FDA.Elite’s lead pipeline products include abuse-deterrent opioids which utilize the company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.), and a Hong Kong based company for development of a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.Elite’s proprietary abuse deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases as intended providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management. The key here is that most physicians think opioid antagonists is the abuse-deterrent formulation that is most needed to combat the opioid abuse epidemic--an issue that's been implicated in the startling rise of the death rate of middle-aged white Americans without a college degree. This painkiller addiction has a big impact on America as there are an estimated 44 deaths per day from prescription painkiller abuse. This has become a major problem and why advances by ELTP are so important to solving this opioid epidemic.The next step for ELTP is with ELI-200. In October, ELTP announced positive top-line results from the Phase 3 pivotal trial of its lead opioid abuse-deterrent candidate, ELI-200, for the treatment of moderate to severe pain. The pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures. There were no serious adverse events or deaths related to ELI-200 reported during the conduct of the trial.We are now just waiting on the NDA for ELI-200. Once that happens we at Insider Financial expect to see 2 to 3 more NDAs this year. We'll at least see NDAs for ELI-201, ELI-202, and possibly ELI-216. Why we think this will happen is because of acceptance by not only physicians, but also from insurance companies to cover ADT opioids. Both will benefit from wrongful death lawsuits and we see Federal and State agencies getting behind the push towards ADT opioids. It's a major problem in America and ELTP is at the forefront of this problem. Matter of fact, ELTP is the solution to the problem!On the company's last earnings call, CEO Nasrat Hakim said:

"We are also very involved in the sales and marketing with our partner Epic for the marketing and distribution of ELI-200. Epic has consultants working very hard with them on detailing the product across the country as a specific physicians and to all pharmacies and they are involving us with every step. As of today our focus remains on ELI-200, on filing it by the end of this year and when I say this year I mean our calendar year meaning December of 2015, by the end of December 2015. We will make an announcement once we receive acceptance of the filing by FDA which most likely will be the first or second week of January unless FDA act faster. So we will file once we receive an acceptance from FDA, we will either issue a press release so have conference call, most likely we'll issue a press release."

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We expect an update on the NDA any day now. With the holidays, it might have gotten delayed by a few extra days. Either way, we think 2016 will be a big one for ELTP. ELTP is one of the very few companies on the OTC markets that has the potential to be a 10-bagger with the potential of its new drugs. ELTP is also a serious candidate to be bought out by a big pharma company looking to be at the forefront of the ADT opioid boom. We will be updating our subscribers as soon as we know more on ELTP. Be sure to sign up and don't miss out on the latest on ELTP!

Disclosure: We have no position in ELTP either long or short. We have not been compensated for this article.