Intellipharmaceutics International Inc. (IPCI)

[InTheTrenches]

From twitter (If you're on twitter, @IPCIPharma is worth a follow):

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IntelliPharma ?@IPCIPharma · 52m52 minutes ago

http://buff.ly/21HCSVW New FDA Chief Cites Promise of Harder-to-Abuse Pain Drugs $IPCI

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Key highlights:


By MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — The Food and Drug Administration's new commissioner is pledging to fully back efforts to develop harder-to-abuse painkillers...

Accepting NDA filing of Rexista 1 would be a good start!

Califf has already pledged to add stronger warning labels to the most-commonly prescribed opioids, and to consult more with outside advisers. On Tuesday he highlighted the potential of new painkillers designed to discourage abuse. For instance, the latest version of OxyContin is harder to crush for snorting. When dissolved it turns into a thick jelly that is difficult to inject.

Again, Rexista...

"But the promise that we are on a path toward products that are effective in preventing abuse both by patients and non-patients is real. And the agency intends to fully support efforts to advance this technology," he said.

Accepting Bio-Equivalent Rexista without a phase 3 will be proof to me that Califf means what he says.

But public speakers warned that overstating the benefits of abuse-resistant opioids could create false assurances in doctors. To date, it's not clear the new formulations actually translate into fewer overdoses or deaths. And most can still be abused when simply swallowed.

"I am not convinced that we can engineer our way out of this epidemic, and I would caution against over-relying on abuse deterrent formulations to do so," said Dr. Caleb Alexander of Johns Hopkins University.

I don't think Califf, Alexander or the mainstream media have heard of Rexista 2 (PODDRAS) yet. Which is a good sign. Market cap of IPCI will steadily increase once Rexista/PODDRAS is in the mainstream media, as it works its way towards approval.

Among other steps, the FDA is requiring additional studies from painkiller manufacturers to assess the long-term safety and effectiveness of long-acting opioids for chronic pain. Most were approved based on studies lasting three months or less.

This may become an issue, if the FDA starts requiring REMS studies. A post-marketing REMS study would be manageable, but a pre-marketing REMS study would cause delays in approval.

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