Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil

Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases. Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases.

Inclusion Criteria:Patients of both sexes who meet all of the following criteria will be included in the study:Age between 18 and 35 years (inclusive).Presence of at least one lower third molar with partial or total bone inclusion (occlusal surface partially or completely covered by bone tissue) with indication for surgical removal (diagnosis made by panoramic radiograph taken within the six [06] months prior to study enrollment), in a vertical, mesioangular or horizontal position according to the Winter classification1,provided they belong to the following Pell & Gregory classes2:Impacted lower third molar in vertical or mesioangular position: may be included, as long as it belongs to Pell & Gregory classes Ia, Ib, IIa or IIb;Lower third molar impacted in a horizontal position: may be included, as long as it belongs to Pell & Gregory classes Ia, Ib or IIa.Exclusion Criteria:Patients who meet at least one of the following criteria will be excluded from the study:Presence of previous inflammatory and/or infectious oral lesion with indication for the use of anti-inflammatory agent and/or antibiotic therapy.Presence of any oral lesion in the region of the third molar to be extracted that may contraindicate extraction, at the discretion of the dental team (for example, pericoronitis, periodontitis, cysts, among others).Smoking* *Any use of tobacco, including e-cigarettes, is prohibited during the study. In the case of the participant who occasionally smokes, he/she must be willing not to use tobacco throughout his/her participation in the study.