$CURE Pharmaceutical Holding Corp. (CURR) Breaking
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Posted On: 02/20/2020 12:18:05 PM
$CURE Pharmaceutical Holding Corp. (CURR) Breaking through the controlled substance stigma to deliver new treatment paradigms
Jessica Rousset, COO, CURE Pharmaceutical.
With the first FDA-approved cannabis extract (Epidiolex) emerging from the stigma of recreational cannabis, the pharmaceutical industry has taken notice of the potential therapeutic uses of scheduled drugs with no currently accepted medical use, says Jessica Rousset, COO at CURE Pharmaceutical.
“Last year, the FDA fast-tracked studies evaluating the safety and effectiveness of MDMA to treat PTSD and psilocybin for the treatment of depression,” she says, adding that compounds such as ibogaine and its prodrug, noribogaine, show promise in the treatment of alcoholism, cocaine and opioid addiction.
Working with the FDA, Risk Evaluation and Mitigation Strategies (REMS) can be established to mitigate risks of abuse and diversion without limiting their access to patients who have often exhausted all approved treatment options.
Rousset argues that as these ‘alternative’ treatment strategies go mainstream, manufacturers will be looking to leverage alternative formulations to deter abuse, widen the therapeutic index, accelerate onset and ensure precise dosing: “For example, Spravato (Esketamine) was approved for treatment resistant depression as a nasal spray for rapid delivery to the CNS without undergoing first pass metabolism.”
She says this avoidance of pills being digested is important because liver damage has already occurred in a significant subset of patients taking Epidiolex.
“Next generation formulations, such as buccal and sublingual dose forms, can offer meaningful improvements to patients taking these first in class therapies,” she concludes.
https://www.cphi.com/northamerica/en/about/ne...-2020.html
Jessica Rousset, COO, CURE Pharmaceutical.
With the first FDA-approved cannabis extract (Epidiolex) emerging from the stigma of recreational cannabis, the pharmaceutical industry has taken notice of the potential therapeutic uses of scheduled drugs with no currently accepted medical use, says Jessica Rousset, COO at CURE Pharmaceutical.
“Last year, the FDA fast-tracked studies evaluating the safety and effectiveness of MDMA to treat PTSD and psilocybin for the treatment of depression,” she says, adding that compounds such as ibogaine and its prodrug, noribogaine, show promise in the treatment of alcoholism, cocaine and opioid addiction.
Working with the FDA, Risk Evaluation and Mitigation Strategies (REMS) can be established to mitigate risks of abuse and diversion without limiting their access to patients who have often exhausted all approved treatment options.
Rousset argues that as these ‘alternative’ treatment strategies go mainstream, manufacturers will be looking to leverage alternative formulations to deter abuse, widen the therapeutic index, accelerate onset and ensure precise dosing: “For example, Spravato (Esketamine) was approved for treatment resistant depression as a nasal spray for rapid delivery to the CNS without undergoing first pass metabolism.”
She says this avoidance of pills being digested is important because liver damage has already occurred in a significant subset of patients taking Epidiolex.
“Next generation formulations, such as buccal and sublingual dose forms, can offer meaningful improvements to patients taking these first in class therapies,” she concludes.
https://www.cphi.com/northamerica/en/about/ne...-2020.html
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