Elite Pharmaceuticals Inc (ELTP)

[Couch]

ELTP ADT opioids that doctors can feel safe prescribing. If you were a doctor in this prescription abuse epidemic environment, what would you prefer to prescribe for pain management: An opioid without abuse deterrent technology or an opioid with abuse deterrent technology??? ELTP is betting on the latter.

Sen. Manchin targets prescription drug epidemic

http://www.wvgazette.com/article/20150407/GZ01/150409420

The biggest problem we have is the doctors who are killing people because they’re habitually overprescribing,” Manchin said Tuesday in Charleston. “Unless we go after these doctors, we’re no going to stop this. They’re getting too much money seeing these patients every day.”

Under Manchin’s first bill — called the “FDA Accountability for Public Safety Act” — the agency’s panel would be required to review new opioid-based medications used to treat pain. The FDA would have to submit reports and testify before Congress before such medications received final approval.

Congress makes fervent push for abuse-deterrent painkillers

http://www.washingtonexaminer.com/congress-pushes-for-abuse-deterrent-pills/article/2563258

he most common abuse-deterrent technology prevents a pill from being snorted, usually by having it turn into a gel after it is crushed. The technology also prevents an abuser from chewing the pill to get a high more quickly.

The FDA finalized a draft regulatory guidance from 2013 on how drug makers can adopt abuse-deterrent technology. If it hadn't done so by June the agency would have lost $20 million in funding from Congress, a threat that the agency apparently took seriously.

Earlier this week Sen. Joe Manchin, D-W.Va., introduced new legislation to revamp how the FDA approves drugs. Manchin was furious with the agency in late 2013 when it approved a painkiller called Zohydro without abuse-deterrent features.

The bill forces the FDA to justify why it would ignore recommendations from its advisors in approving a new painkiller. Agency advisors recommended Zohydro be rejected because of its abuse potential, but the FDA approved it anyway.