According to a recent article, PharmaTher Holdings Ltd. announces the FDA granted orphan drug designation (ODD) for ketamine in the treatment of complex regional pain syndrome (CRPS).
Complex regional pain syndrome (CRPS), a chronically painful condition, most often affects a person’s arms, legs, hands, or feet. Its onset usually occurs after an injury to the affected area and is thought to stem from damage to the central (brain/spinal cord) or peripheral (brain/spinal cord signals to the body) nervous system. Most often, people experiencing CRPS suffer excessive or prolonged pain, as well as skin color changes, swelling, and a change in temperature to the area affected. The symptoms of CRPS can vary in length and severity, but most cases are mild and resolve over time. Other people may be left with certain levels of disability if resolution does not occur. CRPS is more common among women, but anyone can be affected. The average age of those affected is 40, and children very seldom have it prior to age 10.
People with CRPS report experiencing constant and prolonged pain that can feel like pins and needles, or may manifest as a burning sensation. The pain can spread from a localized area to the entire limb, for example, starting in the hand, then spreading to the shoulder. Often, even a light touch can be painful. This is called “allodynia.” Their skin can appear thin and somewhat shiny, and joints can stiffen.
Complex regional pain syndrome currently does not have any approved treatment. Ketamine is being researched as a treatment option because it is a noncompetitive, NMDA blocker that can prevent the induction of synaptic potentiation. This makes it a candidate since NMDA receptors are central in the processes of induction and maintenance of pain sensitization.
The Orphan Drug Act
The Orphan Drug Act gives special status to a drug or biological product for the treatment of a rare disease or condition if requested by a sponsor. By granting “orphan status” to products that treat rare disease, the FDA is incentivizing sponsors to create more drugs and biologics.
PharmaTher Holdings Ltd. is a clinical-stage psychedelics biotech company that specializes in the research, development, commercialization, formulations, and delivery methods of psychedelics in order to treat mental health, neurological disorders, and pain disorders.
“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.” – Fabio Chianelli, Chief Executive Officer of PharmaTher