Cycloserine/lurasidone
| Combination of | |
|---|---|
| Cycloserine | NMDA receptor modulator |
| Lurasidone | Atypical antipsychotic |
| Clinical data | |
| Other names | NRX-101; Cyclurad |
| Routes of administration | By mouth |
| ATC code |
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| Legal status | |
| Legal status | |
Cycloserine/lurasidone, developmental code name NRX-101 and tentative brand name Cyclurad, is a combination formulation of the antibiotic D-cycloserine, an antagonist of the glycine site of the NMDA receptor, and lurasidone, an atypical antipsychotic, which is under development by NeuroRx for the treatment of acute suicidal ideation/behavior (ASIB).[1] As of May 2016, it has completed a phase II clinical trial for bipolar depression. In September 2017, the drug received fast track designation for bipolar depression from the United States Food and Drug Administration.[2]
Currently preclinical information on Cyclurad comes from two phase II clinical trials looking at the significance/efficacy of D-cycloserine in the treatment of depression, in which D-cycloserine could be a cost-effective target for novel pharmaceutics (Phase II). There is a clinical trial slated[3] for treatment of ASIB; however, enrollment for the study has not been started as of yet. The investigators will administer an intravenous infusion of ketamine 0.5 mg/kg over 40 minutes, and if the patients respond satisfactory, as deemed by the investigators, then they will be administered a dose Cyclurad or to a comparator group. This clinical trial is in part supported by a letter the editor in the Journal of Clinical Psychiatry, where patients received an acute dose of ketamine, followed by daily D-cycloserine. Patients appeared to show a decrease in depression scores, based Hamilton Depression Rating Scale and Beck Depression Inventory, in the treatment arm.[4] Along with this letter, D-cycloserine was also used in a similar scenario with treatment resistant depression. In this trial, patients were administered either D-cycloserine or a placebo. The main significance of this trial were not just the results from the treatment, but the fact that D-cycloserine, which is an NMDA antagonist, has potential therapeutic role in treating depression.[5]
See also
References
- ^ "Official page about NeuroRX NRX100/NRX101".
- ^ "Cycloserine/lurasidone - NeuroRx". Adis Insight. Springer Nature Switzerland AG.
- ^ Clinical trial number NCT02974010 for "Sequential Therapy for the Treatment of Severe Bipolar Depression. (STABIL-B)" at ClinicalTrials.gov
- ^ Kantrowitz JT, Halberstam B, Gangwisch J (June 2015). "Single-dose ketamine followed by daily D-Cycloserine in treatment-resistant bipolar depression". The Journal of Clinical Psychiatry. 76 (6): 737–8. doi:10.4088/JCP.14l09527. PMID 26132675.
- ^ Heresco-Levy U, Gelfin G, Bloch B, Levin R, Edelman S, Javitt DC, Kremer I (April 2013). "A randomized add-on trial of high-dose D-cycloserine for treatment-resistant depression". The International Journal of Neuropsychopharmacology. 16 (3): 501–6. doi:10.1017/S1461145712000910. PMID 23174090.
External links
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