gabapentin/trazodone / Angelini Group - LARVOL DELTA

Efficacy and Safety of Trazodone and Gabapentin Fixed-Dose Combination in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose-Finding Study. (PubMed, Pain Ther) - P2 | "The primary end point of the study was the change from baseline of the average daily pain score based on the 11-point NRS after 8 weeks of treatment. While the primary endpoint was not reached, patients treated with Trazo/Gaba 2.5/25 mg t.i.d. showed statistically significant improvement of pain and other scores after 6 weeks and reported consistent better results in comparison to PLB on primary and secondary endpoints for the overall study duration. According to these results, the lowest dose of Trazo/Gaba FDC may be the best candidate for further clinical development to confirm the potential benefits of the FDC drug for this condition."

Clinical • Journal • CNS Disorders • Depression • Diabetes • Diabetic Neuropathy • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Mood Disorders • Neuralgia • Pain • Psychiatry

PK/PD analysis of trazodone and gabapentin in neuropathic pain rodent models: Translational PK-PD modeling from nonclinical to clinical development. (PubMed, Clin Transl Sci) - "On this basis, several simulations were performed to identify possible starting dose combinations of trazodone and gabapentin in humans, by selecting doses yielding systemic exposures close to those being synergic in the mouse. Simulations indicated that doses of 50-100 mg trazodone could enhance gabapentin antinociceptive effect in humans, supporting the development of a low dose combination for optimal analgesia treatment."

Journal • PK/PD data • Preclinical • Neuralgia • Pain

Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy (clinicaltrials.gov) - P2; N=240; Completed; Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A; Recruiting ➔ Completed; Trial completion date: Dec 2020 ➔ Jun 2020

Clinical • Trial completion • Trial completion date • Diabetic Neuropathy • Pain

Synergistic interaction between trazodone and gabapentin in rodent models of neuropathic pain. (PubMed, PLoS One) - "Besides exerting a significant antinociceptive effect on hyperalgesia and on spontaneous pain, combined inactive doses of trazodone and gabapentin restored in CCI rats innate behaviors that are strongly reduced or even abolished during persistent nociception, suggesting that the combination may have an impact also on pain components different from somatosensory perception. Our results support the development of a trazodone and gabapentin low doses combination product for optimal multimodal analgesia treatment."

Journal • Preclinical • CNS Disorders • Depression • Mood Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Psychiatry

Investigations on dose proportionality and drug-drug interaction for a fixed-dose combination of trazodone and gabapentin. (PubMed, Int J Clin Pharmacol Ther) - "To our knowledge, for the first time, proportionality for trazodone at doses of 2.5 to 30 mg and for gabapentin at doses of 25 to 300 mg was investigated. Absence of a pharmacokinetic interaction was shown."

Journal • Fatigue

[VIRTUAL] LOW-DOSE COMBINATION OF TRAZODONE AND GABAPENTIN IN PAINFUL DIABETIC NEUROPATHY: THE USE OF ELECTRONIC CLINICAL OUTCOME ASSESSMENT (ECOA) IN A RANDOMIZED CONTROLLED CLINICAL TRIAL (WIP 2020) - "The use of ECOA is expected to bring several advantages especially in a complex clinical trial, in terms of controlled data entry, efficiency, quality, real-time access and data transfer, patient retention and investigators’ and patients’ engagement."

Clinical • Clinical data • CNS Disorders • Depression • Diabetic Neuropathy • Mood Disorders • Pain • Psychiatry