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Insys Therapeutics Inc (NASDAQ:INSY) Extends Compassionate Use Trials Of Cannabidiol for Refractory Pediatric Epilepsy

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Insys Therapeutics Inc

Insys Therapeutics Inc (NASDAQ:INSY) has extended the compassionate use trials of its proprietary oral formulation of CBD for the cure of refractory pediatric epilepsy, allowing patients from previous clinical studies of the investigational drug to continue getting it as per the protocols originally approved by the U.S. FDA and under the guidance of their physicians.

The details

The original 48-week extended access program after a long-term safety trial that permitted patients who had concluded the initial 10-day pharmacokinetics and safety trial to continue getting the firm’s CBD oral solution at doses up to 40 mg per kg per day for up to 48 weeks. In the preliminary PK and safety study, 61 subjects with refractory epilepsy between the ages group of 1 and 17 years were given total daily doses of 10 mg per kg, 20 mg per kg or 40 mg per kg. Of these 61 subjects, 52 continued into the long-term safety trial, of which 45 have concluded 48 weeks of treatment across numerous investigative sites in the U.S.

Expanded access offers a pathway for subjects to gain access to investigational drugs before they are permitted by the FDA. Around 31 of the 45 subjects in the long-term safety trial of Insys CBD oral solution targeting refractory pediatric epilepsy have registered in the expanded access plan, including 12 under the supervision of Dr. Steven Phillips, M.D. Dr. Phillips, a key investigator in the expanded access trials, all 12 of their families are grateful that they continue to get Cannabidiol for their kids through the expanded access plan for CBD from Insys.

Seizure control has continued to be improved on CBD as against to when not on Cannabidiol, and this effect has been kept for numerous years. As importantly, they have noted minimal side effects with Cannabidiol and an overall improvement in the life quality of patients.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of journaltranscript.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure

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