FDA Accepts IND for Elite Pharmaceuticals Once-Daily Oxycodone Product; Company's Second IND Acceptance in Pain Management.
NORTHVALE, N.J. -- The FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. has accepted Elite Pharmaceuticals, Inc.'s ("Elite" or the "Company") (Amex: ELI Eli (ē`lī), in the Bible, high priest and judge of Israel, teacher of the boy Samuel.
1. (language) ELI - An early system on the IBM 705 and IBM 650.
[Listed in CACM 2(5):16 (May 1959)].
2. ) Investigational New Drug ("IND") application for its once-daily oxycodone oxycodone /oxy·co·done/ (-ko´don) an opioid analgesic derived from morphine; used in the form of the hydrochloride and terephthalate salts.
n. product, traded-named OxyQD(TM).
OxyQD(TM) utilizes Elite's proprietary sustained release Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin technology. Currently there is no once-daily oxycodone on the market. The annual U.S. market for sustained release, twice-daily oxycodone was approximately U.S. $2 billion as of the end of September 2005.
Under the IND for OxyQD(TM), which was submitted for FDA review in late December 2005, Elite will initiate its developmental program by conducting a pilot Phase I study using its sustained release formulation. The study will evaluate the extent of absorption of oxycodone from OxyQD(TM) compared to a current commercial oxycodone product, OxyContin Ox·y·con·tin
A trademark for the drug oxycodone.
ETH-Oxydose, OxyContin, OxyFast, Oxy-IR, Oxynorm (UK), Roxicodone, Supeudol (CA)
Pharmacologic class: Opioid agonist (R), which is a twice-a-day opioid opioid /opi·oid/ (o´pe-oid)
1. any synthetic narcotic that has opiate-like activities but is not derived from opium.
2. any of a group of naturally occurring peptides, e.g. product. Elite's technology for once-a-day oxycodone is protected by a patent pending.
This is the second IND approval for Elite within the past twelve months. The first IND, accepted by the FDA in the second quarter of 2005, was for Elite's opioid abuse resistant product, OxyNal(TM). Under the OxyNal(TM) IND, Elite recently announced positive results for a clinical trial demonstrating that Elite's proprietary technology for its abuse resistant product performs as intended.
"This is another important step forward and a significant milestone in the process of becoming a leader in the development and manufacture of a new generation of pain management opioid drug products," commented chairman and chief executive officer, Bernard Berk. "By providing a once-daily oxycodone, we will be offering the medical practitioner practical alternatives to treat and manage moderate to severe chronic pain which addresses a large unmet medical need. The acceptance of our IND for a once-daily oxycodone, coupled with the positive clinical trial results for our abuse resistant oxycodone OxyNal(TM), are significant technical achievements for Elite. Regulators are encouraging researchers to find solutions to the growing problem of opioid abuse and diversion in this country and provide better, safer, and abuse-resistant pain management drug products. We believe we have the right solution and the best approach in making a difference in the lives of patients who are legitimately seeking pain relief."
About Elite Pharmaceuticals
Elite Pharmaceuticals is a specialty pharmaceutical company principally engaged in the development of oral, controlled release products. The Company's strategy includes developing generic versions of controlled release drug products with high barriers to entry and assisting partner companies in the life cycle management of products to improve off-patent drug products. Elite's technology is applicable to develop delayed, sustained or targeted release capsules or tablets. Elite has one product currently being sold commercially and a pipeline of eight drug products under development in the therapeutic areas that include pain management, allergy allergy, hypersensitive reaction of the body tissues of certain individuals to certain substances that, in similar amounts and circumstances, are innocuous to other persons. Allergens, or allergy-causing substances, can be airborne substances (e.g. , cardiovascular and infection. The addressable Reachable. When something is addressable, it can be identified and manipulated independently of its surroundings. For example, screen pixels and RAM memory are addressable. Each of the screen's picture elements can be individually turned on and off, and each of the memory's bytes can be market for Elite's current pipeline of products exceeds $4.25 billion. Elite also has a GMP GMP (guanosine monophosphate): see guanine. and DEA DEA - Data Encryption Algorithm registered facility for research, development, and manufacturing located in Northvale, NJ.
This news release contains forward-looking statements forward-looking statement
A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , including those related to the preliminary nature of the clinical program results and the potential for further product development, that involve known and unknown risks, delays, uncertainties and other factors not under the control of Elite or Orit, which may cause actual results, performance or achievements of the companies to be materially different from the results, performance or other expectations implied by these forward-looking statements. In particular, because substantial future testing will be required prior to approval, the results described above may not be supported by additional data or by the results of subsequent trials. These risks and other factors, including the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest
administrative body, administrative unit - a unit with administrative responsibilities , and intellectual property protections and defenses, are discussed in the Elite's filings with the Securities and Exchange Commission such as the 10K, 10Q and 8K reports. The companies undertake no obligation to update any forward-looking statements.