Leiden, the Netherlands, September 11, 2024
Synerkine Pharma, a Dutch biopharmaceutical company creating innovative pain solutions, today announced that the European Commission has granted the Orphan Drug Designation (ODD) for SK-01, the company’s most advanced development program, to treat complex regional pain syndrome (CRPS). CRPS, a severe form of chronic pain in which pain from a physical trauma outlasts the expected recovery time, represents a subset of the wider pain medicine market with a high unmet need. Synerkine Pharma is progressing steadily toward the initiation of the first clinical study with SK-01 in CRPS and is currently manufacturing clinical-grade material.
“Chronic pain remains as a global public health problem. The long-term impact of chronic pain extends to mental health problems, fatigue, dependence and other related co-morbidities. More effective treatment options with far better side effect profiles are needed to solve these issues. The emergence of novel non-opioid pain solutions will bring much-needed change to the treatment landscape in CRPS and in other chronic pain indications alike,” commented Hans Preusting, PhD, Chief Executive Officer of Synerkine Pharma.
People living with CRPS experience severe, continuous and in debilitating pain that is much greater than normal. While CRPS can occur anywhere in the body, it often affects a person’s extremities and is usually triggered by previous trauma or injury to the affected body part, leading to increased levels of inflammatory molecules such as cytokines. The condition also occurs more frequent in people with inflammatory and autoimmune disorders, indicating a strong connection between immune system and pain physiology. Severe or long-lasting cases of CRPS are very disabling and can prevent a person from working or living a normal life, resulting in both a personal and familial and a high socioeconomic burden.
The Orphan Drug Designation in the EU was granted by the European Commission based on a positive opinion issued previously by the EMA Committee for Orphan Medicinal Products. The program is focused on the development of drugs that have shown the potential to provide significant benefit to patients suffering from rare, life-altering diseases. Receiving the Orphan Drug Designation adds substantial regulatory and commercial value to Synerkine’s lead development program. Following market approval, the ODD status would provide Synerkine with ten years of market exclusivity in CRPS and provides special incentives, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees.
For more information about Synerkine, we refer you to the company website: synerkinepharma.com.
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