RE: Upload4 Sep 2025 07:19
As to claims around study data, the "strongly positive" Phase II failed to demonstrate any significant post-treatment difference between Fortacin and placebo (the latter giving a mean six-fold increase in IELT over baseline, p=0005, versus an eight-fold increase for Fortacin). No difference in perception of post-treatment benefit between drug and placebo (p=0.3585!). Study data is in the public domain, and explains why no progress has been made in the nearly 30 months since first FDA review. Now, China Phase III did involve a longer treatment period, so perhaps less chance of drug/placebo overlap, although a year on, only RPG have referenced the study, whereas Fosun was very quick to publish the bioequivalence data (publication of Phase III data would not impact on NMPA review). I wonder what Fosun makes of the US data?
The results of the PRO validation study that we previously announced speak for themselves. In this US study, PSD502, marketed as Fortacin™ produced substantial changes in intravaginal latency time (“IELT”) and reduced the level of distress experienced by patients, as reflected in the PEBEQ. These results are entirely consistent with the previous extensive Phase III RCTs that were successfully completed prior to approval by the European Medicines Agency. The changes were clinically and statistically significant both from baseline and from placebo, resulting in an eight-to-nine-fold increase from pre-treatment IELT values. Also consistent with previous RCTs, compliance with therapy and with study requirements was high (over 92% completed in this study), and side effects were minimal. Clinically and statistically significant differences between Fortacin and placebo were observed in the FDA-favoured domain (“Item 3”) of the PEBEQ (p< 0.0008). At the request of the FDA, Item 3 was designed to determine the degree of “bother” that the patients were experiencing due to the condition. For PRO validation, excellent correlations were also observed between changes in Item 3 of the PEBEQ and the domains of sexual satisfaction, control and distress captured using the Index of Premature Ejaculation (“IPE”), one of two PROs used in previous studies. The terms such as “bother” are important because they are used in the final approved prescribing information (“PI”). Overall, the study confirmed the safety and efficacy of Fortacin. This PRO validation study was unique to the US FDA – it was mandated by the FDA and our results were submitted to the FDA. The NMPA in China did not require a validated PRO so Fosun was able to push ahead with the Phase III study.
Sign In
Follow the stocks
