Interim Results of the Remede d'Or Study: A Multicenter, Single-Blind, Randomized, Controlled Trial to Assess the Safety and Efficacy of an Innovative Topical Formulation of Erythropoietin for Treating Diabetic Foot Ulcers.

Objective: To inform on the interim results of the Remede d'Or study, which is a prospective, multicenter, single-blind, randomized, controlled clinical study on the safety and efficacy of RMD-G1, a topical carbopol-based hydrogel with a fibronectin matrix whose active pharmaceutical ingredient is erythropoietin (EPO), for treating diabetic foot ulcers (DFU). Approach: The trial will comprise 20 patients with type 2 diabetes mellitus with neuroischemic DFUs who will be randomized into two groups: (1) a control group in which standard-of-care (SOC) will be used to treat the DFUs, and (2) a test group in which SOC and RMD-G1 will be used to treat the DFUs. On day 0, all participants will be randomized to receive either RMD-G1 and SOC treatment or SOC alone. The primary endpoint of the study is complete closure of the DFU within the 12-week study period following daily treatments and dressing changes. Results: Interim results reveal that those DFUs which were treated with RMD-G1 responded positively: there was a significant reduction in the wound areas. In contrast, the condition of those DFUs which were treated with only SOC deteriorated. Innovation: To date, no topical therapies with proven efficacy for treating DFUs exist. Topical application of EPO-based RMD-G1 in conjunction with SOC to a DFU accelerates their healing and closure. Conclusions: The interim results of this trial indicate that topical RMD-G1 is a safe adjunctive therapy to SOC, which accelerates the closure of a DFU. RMD-G1 is safe pharmaceutical because EPO has a proven safety profile.

Is it possible to achieve bio-equivalence between an oral solid immediate-release and an analogue enteric-coated formulation?

OBJECTIVES: While bioequivalence between enteric-coated and immediate-release formulations can be achieved in terms of AUC, gastric emptying of enteric-coated dosage forms is a stochastic event, usually leading to lower Cmax values than those observed with the corresponding immediate release. This article examines challenges of developing enteric-coated dosage forms which are bioequivalent to the corresponding immediate-release formulations in terms of both AUC and Cmax using rasagiline as a model compound. METHODS: In vitro drug release profiles of enteric-coated formulations were obtained and compared to those of the immediate-release formulation by dissolution testing. Pharmacokinetics was evaluated in bioequivalence studies in healthy human volunteers after single oral administration of enteric-coated and immediate-release formulations. KEY FINDINGS: The initial enteric-coated pellet formulation prototype was equivalent in terms of AUC, but differed in Cmax ; a second formulation prototype, consisting of a single-unit core and enteric-coating film, proved to be bioequivalent to immediate-release rasagiline tablets in terms of AUC and Cmax . In vitro, it released rasagiline rapidly at a pH of 6.8. CONCLUSIONS: Despite differences in gastric emptying between disintegrating immediate-release and enteric-coated solid dosage forms, bioequivalence in pharmacokinetic studies was achieved.