Trevena, Inc.

TRV045

About Diabetic Neuropathic Pain

TRV045 is an Investigational Product not approved by FDA for distribution in the US.

Diabetic neuropathy is a common complication of both type 1 and type 2 diabetes, with pain in the extremities being one of the main symptoms. Other symptoms may include numbness, tingling, allodynia and hyperalgesia.1 Diabetic neuropathic pain is usually characterized as moderate to severe in nature and can substantially affect patients’ quality of life as well as their social and psychological well-being.2

Approximately 25% of people with diabetes – totaling over 5 million people in the U.S. –  are affected by DNP.3,4 During their lifetime, nearly 50% of diabetic patients may experience symptoms of DNP.5 There are few approved therapeutic options for neuropathic pain associated with DNP, and currently available agents do not provide adequate analgesia for an estimated 50% of patients due to lack of efficacy.6,7

About Epilepsy

TRV045 is an Investigational Product not approved by FDA for distribution in the US.

Epilepsy, one of the most common neurological diseases in the world, is a chronic disorder characterized by recurrent seizures. Epilepsy is defined as having two or more unprovoked seizures separated by at least 24 hours or after one seizure with a high risk of more8.

A seizure is a sudden surge of electrical activity in the brain caused by complex chemical changes that occur in nerve cells. Usually, there is a balance of cells that either encourage or stop other brain cells from sending messages. A seizure occurs when there may be too much or too little electrical activity in the brain causing an imbalance9. Seizures are a symptom of many different disorders that can affect the brain. Nearly 50 million people suffer from epilepsy worldwide10, including 3 million adults and 470,000 children in the U.S. 150,000 new cases of epilepsy are reported in the United States each year. According to the CDC, 56% of adults living with diagnosed epilepsy continue to have seizures11.

About TRV045

Trevena is currently developing a novel, selective sphingosine-1-phosphate subtype 1 receptor (S1P1R) modulator, TRV045, as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.

S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.

Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P1R. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. Unlike existing S1PR modulators, TRV045 did not cause lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies.

Program Molecular Target Therapeutic Target Current Phase PC PH1 PH2 PH3 NDA Approved
TRV045 S1P receptor Diabetic neuropathic pain PH1 Oral PC complete PH1 in progress PH2 not started PH3 not started NDA not started Approved not started
TRV045 S1P receptor Epilepsy PH1 Oral PC complete PH1 in progress PH2 not started PH3 not started NDA not started Approved not started
TRV045 is an Investigational Product not approved by FDA for distribution in the US.
  1. Juster-Swityk K, Smith AG. Updates in Diabetic Peripheral Neuropathy. F1000 Research 2016;738.
  2. Quattrini C, Tesfaye S. Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev. 2003 Jan-Feb;19 Suppl 1:S2-8. doi: 10.1002/dmrr.360. PMID: 12577252.
  3. Rosenberger et al., Journal of Neural Transmission, 2020 and CDC National Diabetes Statistics Report, 2020.
  4. Shillo et al., Current Diabetes Reports, 2019.
  5. Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Current Diabetes Reports 2019;19:86
  6. American Diabetes Association
  7. FDA product labels for Lyrica, Lyrica CR, Cymbalta, Nucynta ER, and Qutenza, Tesfaye et.al. Pain (2013).
  8. https://www.epilepsy.com/what-is-epilepsy
  9. https://www.epilepsy.com/causes
  10. https://www.who.int/news-room/fact-sheets/detail/epilepsy
  11. https://www.cdc.gov/epilepsy/about/fast-facts.htm