Elite Pharmaceuticals Inc (ELTP)

[Couch]

4-REASONS-ELTP-is-in-the-Midst-of-the-Perfect-Storm:-A-GREAT-BUY-NOW:

1) Elite Announces U.S. FDA Priority Review Designation For SequestOx™ NDA

http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=80708&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0

The FDA has set a target action date under the Prescription Drug User Fee Act ("PDUFA") of July 14, 2016.

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2) Bowing to pressure, FDA to reform painkiller approval process

http://www.reuters.com/article/us-fda-califf-idUSKCN0VD2MJ

Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama's nominee to lead the Food and Drug Administration, said on Thursday the agency would reform its process for approving opioid painkillers.

The FDA said in its announcement it would develop additional safety information for immediate-release opioid painkillers; strengthen the requirement for drugmakers to produce information after a drug reaches the market; and expand access to abuse-deterrent opioid drug formulations.

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3) MAJORITY OF PUBLIC SUPPORTS REQUIRING ABUSE DETERRENT FORMULATIONS IN MOST-ABUSED PRESCRIPTION DRUGS

http://abusedeterrent.org/news/MAJORITY-OF-PUBLIC-SUPPORTS-REQUIRING-ABUSE-DETERRENT-FORMULATIONS0aIN-MOST-ABUSED-PRESCRIPTION-DRUGS0a.aspx#.VuvYJXg39FJ

McLean, Virginia. A new national survey reports 65% of adults in the U.S. believe the Food & Drug Administration should require pharmaceutical manufacturers to include an abuse deterrent formulation (ADF) in all of their most abused drugs, both name-brand and generic.

With the United States facing its worst prescription drug abuse problem ever, the emerging new technology of ADF’s helps prevent the crushing, snorting and injecting of prescription painkillers when abusers are seeking an immediate high. The FDA has approved labels for 5 Schedule II drugs with abuse deterrent properties, and 9 states have passed legislation related to ADF prescribing, but with no national mandate in place, it is easy for abusers to switch to prescription drugs without an abuse deterrent formulation.

Two-thirds of U.S. adults would also support legislation introduced in the U.S. Congress to mandate that pharmaceutical companies place abuse deterrent formulations in their products within the next four years.

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4) Physicians call for novel abuse-deterrent opioid agonist/antagonist formulations in survey

http://www.fiercedrugdelivery.com/story/physicians-call-novel-abuse-deterrent-opioid-agonistantagonist-formulations/2015-11-09

A survey of more than 200 physicians found that 31% 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.

What type of abuse- deterrent formulation is most needed?

Number (out of 214 respondents)

Opioid antagonist/agonist combination 66 (31%)
Physical or chemical barrier 48 (22%)
Novel delivery system 34 (16%)
Aversion 33 (15%)
Prodrug 14 (7%)
Other or combination of above 19 (9%)
FierceDrugDelivery supplied the question to Quantia MD, the provider of a physician engagement platform that counts one-third of U.S. doctors as its members.

Out of 214 physicians, 66 said opioid antagonists/agonists are the most needed formulation. Opioid antagonists are substances that interfere with the euphoria associated with drug abuse. The deterrents would generally be released and activated only if the product is manipulated, such as during crushing or snorting.