Frequently Asked Questions

  • What is EPM301?

    EPM301 is known as cannabidiol acid methyl ester. Cannabidiol acids (CBDA) are unique to cannabidiol (CBD) in their stability, affinity for cannabinoid receptors and pharmacokinetics.  Studies support cannabidiol acids are 10 to 100 times more potent than CBD.  Cannabidiol acids were originally isolated then stabilized in the laboratories of Raphael Mechoulam at Hebrew University in Jerusalem.  epm Therapeutics licensed 14 of these molecules and selected EPM301 to advance in to clinical development for the treatment of multiple symptoms often experienced by PWS patients.

  • What is the status of EPM301 with the USFDA (United States Food and Drug Administration)?

    EPM301 has been granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) by the USFDA.  With the approval of a NDA (New Drug Application) we will be eligible for a Priority Review Voucher (PRV) based on the US Congress recently renewing the program.  EPM301 is also designated an Orphan Drug by the European Union’s EMA (European Medicines Agency).

    epm Therapeutics recently completed a pre-IND interface with the USFDA and can confirm that our pre-clinical development program(s) and plans  developed  for clinical studies appear to be adequate for IND application.


  • What symptoms of PWS (Prader Willi syndrome) does EPM301 have the potential to treat?

    From initial animal model studies EPM301 has shown the potential to have a clinical effect to improve the symptoms of hyperphagia (uncontrollable/insatiable appetite), sleep/wake cycle (narcolepsy) and certain mood disorders such as obsessive-compulsive disorder (OCD) and irritability.  In anticipation of and IND (Investigational New Drug) approval, epm Therapeutics is developing protocols to investigate these potentials in humans.

  • Where is EPM301 in development at this point?

    EPM301 is currently in pre-clinical development and accumulating data proceeding toward an application to the USFDA (United States’ Food and Drug Administration) for an IND (Investigational New Drug).   

  • How can caregivers support epm Therapeutics and the development of EPM301?

    epm Therapeutics continually updates our website and communicates on both Facebook and LinkedIn.  Please follow us.  If you have any comments, ideas or suggestions for us, please communicate them!  Also, in communications with your peers and advocacy groups please keep us in mind as an active and supportive member of the PWS community.

  • Can you tell us more about epm Therapeutics?

    epm Therapeutics was founded in 2017 with the licensing of our intellectual property (IP) from the Hebrew University in Jerusalem.  We are incorporated in the United States as EPM Group Inc. (Nevada) and doing business as (dba) epm Therapeutics.  We are privately held.  

    While we hold a portfolio of 14 different molecules of CBDA and CBG our current focus is exclusively on the development of our EPM301 for the treatment of multiple symptoms of PWS (Prader Willi syndrome).

    Our corporate headquarters is located at 7310 Turfway Road, Suite 550, Florence, KY 41042.  You can reach us at 859-648-3367 or 859-487-9858 or by email at letstalk@epmtherapeutics.com or investorrelations@epmtherapeutics.com