PharmaTher Granted FDA Orphan Drug
Designation For Ketamine To Treat Complex Regional Pain
Syndrome
-
Achieving its
second FDA orphan drug designation with ketamine.
-
Building a
proprietary ketamine-based product pipeline for rare and near-rare
disorders in pain and inflammation.
-
Seeking to enter
Phase 2 clinical trial in 2022.
TORONTO, October 13, 2021 -- InvestorsHub NewsWire --
PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB:
PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech
company, is pleased
to announce that the U.S. Food and Drug Administration (FDA) has
granted orphan drug designation (ODD) for ketamine in the treatment
of complex regional pain syndrome (CRPS), a rare chronic pain and
inflammatory condition following an injury to a limb (arm, leg,
hand or foot).
This follows the FDA ODD
grant of ketamine for the treatment of Amyotrophic Lateral
Sclerosis (ALS), also known as Lou Gehrig's disease, announced by
the Company on August 4, 2021.
Fabio Chianelli, Chief
Executive Officer of PharmaTher, said, "Receiving our second FDA
orphan drug designation with ketamine for CRPS continues our
momentum in building a specialty ketamine-based
product pipeline for
not only mental health disorders, but also for rare and near-rare
conditions present in neurological (Parkinson's
disease, ALS), pain and inflammatory disorders. We expect to pursue a Phase
2 clinical study using our proprietary cGMP ketamine product in
2022 for CRPS."
CRPS is a debilitating
condition characterized by severe, continuous, burning or throbbing
pain in a limb. CRPS
is known as one of the most painful disorders and the risk of
suicide is significantly higher in patients with CRPS with one
study demonstrating that 75% of patients had a high risk for
suicide (Lee et al., Psychiatry Investig
2014;11(1):32-8). CRPS has acute (recent, short-term) and
chronic (lasting greater than six months) forms of excessive pain
accompanied by changes in skin color, temperature and/or swelling,
which results in loss of physical function and can lead to
significant and sometimes permanent disability.
CRPS can occur
after surgery or trauma, including brain or spinal cord
injury. There is currently no medication
approved for the treatment of CRPS.
Ketamine acts as a
noncompetitive, NMDA channel blocker that can prevent the induction
of synaptic potentiation. NMDA
receptors play a central role in the processes of induction and
maintenance of pain sensitization, accounting for the analgesic
efficacy of ketamine. Although
ketamine has actions at other relevant sites, including nicotinic
and opioid receptors, as well as, via monoamine reuptake
transporters, it is likely that both the anesthetic and the
analgesic actions of ketamine are largely mediated by NMDA receptor
antagonism. Likewise,
the psychotropic and sympatho-excitatory side effects of ketamine
are also predominantly mediated through NMDA receptor
blockade.
The Orphan Drug Act grants
special status to a drug or biological product to treat a rare
disease or condition upon request of a sponsor. This status is
referred to as orphan designation (or sometimes "orphan status").
The FDA grants orphan status to products that treat rare diseases,
providing incentives to sponsors developing drugs or biologics. The
FDA defines rare diseases as those affecting fewer than 200,000
people in the United States at any given time. Orphan drug
designation would qualify a drug for certain benefits and
incentives, including seven years of marketing exclusivity if
regulatory approval is ultimately received for the designated
indication, potential tax credits for certain clinical drug testing
costs, activities, eligibility for orphan drug grants, and the
waiver of the FDA New Drug Application filing fee of approximately
$2.4 million.
About PharmaTher Holdings
Ltd.
PharmaTher Holdings Ltd.
(OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company
focused on the research, development and commercialization of novel
uses, formulations and delivery methods of psychedelics, such as
ketamine, to treat mental health, neurological and pain
disorders. PharmaTher is currently initiating an
FDA approved phase 2 clinical study with ketamine to treat
Parkinson's disease and is developing a novel microneedle patch for
the intradermal delivery of psychedelics.
Learn more
at:
PharmaTher.com and follow us on
Twitter and
LinkedIn.
For more information about PharmaTher, please
contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
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