The path to a successful SPA requires thorough preparation and seamless execution. Camargo has extensive experience in developing successful spa agreements with the FDA and can help manage the uncertainty surrounding ASS. Contact Camargo for strong policy recommendations for the effective use of a SPA as part of a 505 (b) (2) drug development program. 1) Written agreement between the FDA and the sponsor, or the protocols likely to be submitted to the SPA application are animal carcinogenicity protocols, pharmaceutical and pharmaceutical stability protocols, animal efficacy protocols, testing protocols intended to serve as the basis for efficacy and protocols necessary for clinical trials to demonstrate biosimilarity or interchangeability of the proposed biosimilar. Special Protocol AuditThe SPA procedure is a procedure by which the FDA provides formal assessments and written guidelines on the design and size of proposed Phase 3 protocols, which will serve as the basis for an NOA. For more information on the SPA process, see: www.fda.gov/regulatory-information/search-fda-guidance-documents/special-protocol-assessment-guidance-industry. « VVC is a widespread and serious disease with significant morbidity, but there is only one oral option to treat acute episodes and no authorized product for the prevention of VVC relapse, » said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. « This spa agreement for the design of CANDLE`s Phase 3 studies illustrates the regulatory pathway for admission to recurrent VVC. The results of this study and the two ongoing acute VVC studies, Phase 3, may support the positioning of oral ibrexafungerp as the primary means of VVC treatment and relapse prevention. In addition, a sub-study nested in the CANDLE study will provide valuable data to assess the efficacy of Ibrexafungerp in patients with VVC, even multiple doses of fluconazole have not been sufficiently resolved by acute infection, which will differentiate ibrexafungerp from currently available treatments. While an SPA agreement indicates that the FDA has found that the sponsor`s proposed study has been properly developed to support the FDA`s acceptance criteria for its NDA or BLA, a SPA does not guarantee the success of the product`s application. Correction of the SPA agreement may occur if the proponent does not fully comply with the agreed protocol or if the final test results are not favourable.
Even if the study is conducted as planned and the agreed objectives are successfully met, the FDA may refuse to submit or approve the application. The CANDLE study is a phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy and tolerance of oral Ibrexafungerp versus placebo in women with relapsed CVV (defined as three or more in the past 12 months). The main endpoint of the study is efficacy, measured by the percentage of patients without recurrence of VVC, until their Cure test evaluation (OCD) at week 24. The secondary criteria of the study are the evaluation of VVC recurrences at other times, the time of reappearance, the eradication of mycological and the evaluation of quality of life. All patients in the CANDLE study initially receive three doses of oral fluconazole to treat their acute episode present during screening. Patients who respond to oral fluconazole for their acute episode are enrolled in preventing the recurrence period of the study and are randomized to oral ibrexafungerp (300 mg of IDB for one day) or placebo, once a month for a total of six days of treatment. Patients who do not respond sufficiently to fluconazole treatment for their acute episode are included in a nested open-label sub-study that offers them a day of oral treatment with ibrexafungerp (300mg of IDB) for their unresolved acute episode. Clinical protocols for Phase 3 trials may refer to efficacy applications that will be part of a new initial application (NDA) or a new Application of the License (BLA) or an additional efficacy to an approved NOA or BLA.