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Elite Pharmaceuticals Announces Positive Top-Line Results From a Pivotal Phase 3 Study for Abuse-Deterrent Opioid ELI-200 Meets Primary and Secondary Endpoints
NORTHVALE, N.J., Oct. 21, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today 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.
Elite intends to submit a New Drug Application to the U.S. Food and Drug Administration for abuse-deterrent ELI-200 by year-end.
"I am pleased with completing this important step in the commercialization of our first abuse-deterrent product, ELI-200," said Nasrat Hakim, President and Chief Executive Officer of Elite. "The next significant step will be the submission of the NDA for ELI-200 which I expect to occur by year-end."
About the Phase 3 ELI-200 Trial
The Phase 3 study evaluated safety and efficacy following dosing of ELI-200 for the treatment of moderate to severe pain following surgery. It was a multicenter, randomized, multiple-dose, double blind, placebo-controlled, and parallel group study. The clinical trial was conducted at five study sites in the United States which randomized 163 patients into the clinical study.
About Elite's Abuse Deterrent Technology
Elite's proprietary abuse deterrent technology, ARTâ„¢, 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.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. 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.
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=79416&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0
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For the new investors, below is the trial link
https://clinicaltrials.gov/ct2/show/NCT02401750?term=%22Elite+Laboratories%2C+Inc%22&rank=1
Awesome!!! Today starts a new chapter!!! Glad to be part of it!!
This Thursday is October!!! Notice the increase in volume and the wild price action$$$$$
ELTP-price action an volume!!!
Buy time or be left in the dust.
ELTP starting to lift off. Phase 3 results in October!!
I liked the increased volume at the bell yesterday! Hopefully it continues into today. GLTA!
Bull pennant forming on 2 hour and 1 hour charts.
ELTP bull Pennant forming on 2 hour and 1 hour charts. Closed just above 200sma.
I emailed the Abuse Deterrent Coalition on ELI-200. This was their response:
HI Craig,
Thanks for your note. ELI-200 is designed as a long acting opioid, using and agonist-antagonist ADF formulation – naltrexone combined with the active pain relief opioid. The AD Coalition supports Elite Pharma’s efforts to bring its product through clinical trials and ultimately to the market with an ADF formulation designed to deter abuse. Like you, we will watch for the results of the current Phase III efficacy trial and look forward to learning about the data.
Thought about it. Did my DD. I am out.
Big scam!!
Look at the ELTP weekly chart. 200sma is at .19. Look back at the past 2.5 years . It will give you a better story of what is happening here. GL.
Things that make you go mmmm...
Look at level 2!! They want to push this stock North!
The trend looks a little different this time around. Looks kind of like August of 2013!
Looks like it is taking a dump before the CC this time around.
This stock will run just like Lexicon
Elite Pharmaceuticals Completes Enrollment and Dosing for ELI-200 Phase III Efficacy Trial
Elite Pharmaceuticals, Inc.
1 hour ago
GlobeNewswire
????
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NORTHVALE, N.J., Aug. 3, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (ELTP), today announced the completion of patient enrollment and dosing for the Phase III efficacy trial for ELI-200, an abuse-deterrent opioid product. This Phase III trial is designed to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. The study enrolled 163 patients at five clinical sites. Top-line efficacy and safety data from this study are expected to be announced near year's end. Submission of the NDA for ELI-200 is also expected shortly thereafter. "I am very pleased that we have completed enrollment, surgeries and dosing for Elite's Phase III trial for ELI-200," stated Nasrat Hakim, President and Chief Executive Officer of Elite. "We expect the NDA submission for ELI-200 near year's end, and in preparation for an ELI-200 launch in 2016, we are expanding our facility and working with our sales partner, Epic Pharma, on pre-launch activities."
C H E E R $ !
Report TOS
LXRX soared today after their positive phase 3 results. Hoping the same for Elite!
Elite Pharmaceuticals Completes Enrollment and Dosing for ELI-200 Phase III Efficacy Trial
Elite Pharmaceuticals, Inc.
1 hour ago
GlobeNewswire
????
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ELITE PHARMACEUTICALS INC /NV/ Financials EDGAR Online Financials 1 mth 14 days ago
10-K for Elite Pharmaceuticals, Inc. Company Spotlight 1 mth 16 days ago
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NORTHVALE, N.J., Aug. 3, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (ELTP), today announced the completion of patient enrollment and dosing for the Phase III efficacy trial for ELI-200, an abuse-deterrent opioid product. This Phase III trial is designed to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. The study enrolled 163 patients at five clinical sites. Top-line efficacy and safety data from this study are expected to be announced near year's end. Submission of the NDA for ELI-200 is also expected shortly thereafter. "I am very pleased that we have completed enrollment, surgeries and dosing for Elite's Phase III trial for ELI-200," stated Nasrat Hakim, President and Chief Executive Officer of Elite. "We expect the NDA submission for ELI-200 near year's end, and in preparation for an ELI-200 launch in 2016, we are expanding our facility and working with our sales partner, Epic Pharma, on pre-launch activities."
C H E E R $ !
Report TOS
I agree
Maybe the start of a run like in August of 2013. Keep your fingers crossed.
Hammer Candle on the daily!!!
Why advertise without approval. If it fails you have thousands of people disappointed instead of hundreds.
It will happen. Patience is key.
Looking at the 15 and 30 min ELTP chart it looks like it is taking a turn North. I am very long on this stock but ready for it to move up some. Would love a close above .225!
A must read for any biotech investor!! I loved the article. explains a lot!!!www.biotechpicklist.com/bioinvesting/
Mine wasn't. LOL!!
Who cares.
ELTP
Elite Pharmaceuticals and Epic Pharma Enter Into a Sales and Distribution Licensing Agreement for Abuse-Deterrent ELI-200
NORTHVALE, N.J., June 9, 2015 (GLOBE NEWSWIRE)
http://globenewswire.com/news-release/2015/06/09/743155/10137768/en/Elite-Pharmaceuticals-and-Epic-Pharma-Enter-Into-a-Sales-and-Distribution-Licensing-Agreement-for-Abuse-Deterrent-ELI-200.html
-- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP) announced today that it has entered into a sales and distribution licensing agreement with Epic Pharma LLC for ELI-200 (the "License"), an abuse-deterrent opioid utilizing Elite's proprietary pharmacological abuse-deterrent technology. Epic will be responsible for sales and marketing of ELI-200, and Elite will be responsible for the manufacture of the product. Epic will pay Elite non-refundable milestone payments totaling $15 million and a royalty based on net product sales. The term of the License is five years and the License is renewable upon mutual agreement at the end of the initial term.
Elite also announced today the dosing of the first subjects for an ELI-200 Phase III clinical study. This Phase III study is a multi-center, randomized, multiple-dose, blinded, placebo-controlled, parallel group, study to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. The study will enroll approximately 165 patients at five clinical sites.
"Epic is pleased to have an opportunity to market this important new product and to add to our current pipeline of opioid products that includes a pending application for an abuse-deterrent oxycodone HCl extended release product," said Dr. Ashok Nigalaye, Chief Executive Officer of Epic. "ELI-200 will allow Epic to extend its reach in the anti-abuse pain space, and to position both companies for long-term growth."
"I am delighted to have a partner like Epic for Elite's first abuse-deterrent product," said Nasrat Hakim, President and Chief Executive Officer of Elite Pharmaceuticals. "We will work closely with Epic to prepare for and ensure a successful launch. The ELI-200 Phase III study is expected to be wrapped up later this year and we expect an NDA filing for ELI-200 by year's end."
Additional information about the licensing agreement and Phase III clinical trial will be provided at our yearend conference call following the filing of our annual report on form 10-K for the fiscal year ended March 31, 2015. We anticipate that the conference call will be held on June 16th, 2015. Additional information about the conference call will be provided.
http://globenewswire.com/news-release/2015/06/09/743155/10137768/en/Elite-Pharmaceuticals-and-Epic-Pharma-Enter-Into-a-Sales-and-Distribution-Licensing-Agreement-for-Abuse-Deterrent-ELI-200.html'
The PPS will probably be stuck in between the 200 and 50 sma until they cross which will probably happen when the phase 3 trial is complete. I believe July could get exciting! I would not want to be on the sidelines come this summer. GLTA.
I agree it needs to A) up list off the OTC and B) ART needs to be approved. I will be here to find out.
Keep your eye on the prize in 2016. Patience is hard and I struggle with it too. I have to keep doing DD to keep me focused and not give in.
Bb's and SMA's are looking good.
Give it a couple more minutes:)
Should be heading north shortly.
It should be a fun ride this week! Time to go up the hill!!
ELTP just broke above 10, 50 and 200sma on 5 min chart!!!