A novel drug therapy for treatment-resistant depression, adjunct 5HTP slow release

Selective serotonin-reuptake inhibitors (SSRIs) are used as first line pharmacotherapy in depression but only one third of patients will recover with this treatment. 5-hydrxytryptohan (5-HTP) is used to elevate serotonin levels in the brain for depression patients who are resistant to SSRI. However, 5-HTP drugs have a short half-life and is rapidly metabolized. A sustained release 5-HTP drug (SR) targeting colon release and absorption is developed in this project.

Market Impact

Depression affects 350 million people globally (WHO). The one-year prevalence is ~6% and life-time prevalence is ~16%. Depression is a key risk factor for suicide, but also increases the risk of cardiovascular disease, cancer and diabetes. On average, depression shortens life span by 8 years. Depression significantly impairs vocational and scholastic performance, and has a major negative impact on the economy.

Technology Description

A 5-HTP SR drug is developed as a new treatment for treatment-resistant depression (TRD). Adjunct 5-HTP SR will use sustained administration of the natural precursor of 5-HT (serotonin), i.e. 5-HTP, to elevate brain 5-HT synthesis. Through this, 5-HTP SR will exploit a novel, yet semi-precedented, mechanism of action – elevating 5-HTExt beyond the SSRI effect, in a sustained fashion and with appropriate safety. No current drug uses this mechanism.

Adjunct 5-HTP SR will be an easy-to-administer once or twice daily oral tablet therapy.

Development Status

Extrusion into microtubes has been undertaken by an industry vendor and has demonstrated the formulation to have enhanced strength compared to commercially available stent formulations. Cytotoxicity and biocompatibility studies, loading simulations and degradation studies are underway.

Current IP position: Provisional patent application filed.

Future Progress

Upon successful in vivo demonstration of this technology’s safety and efficacy, the technology is ideally placed as a licensing opportunity to MNC / SME operating in stent manufacturing fields.