Efficacy and Safety of DNN.63.18.040 for the Treatment of Moderate to Severe Pain

• Male or female participants aged 18 years or older and younger than 50 years;
• Underwent extraction of up to 2 impacted third molars requiring bone removal (ostectomy), classified as Pell and Gregory Class II or III and Position B or C;
• Following third molar extraction surgery, experienced moderate to severe pain, defined as a score ≥5 on an 11-point Numeric Rating Scale (NRS), within 5 hours after dental extraction.

Exclusion Criteria:

• Surgical duration greater than 4 hours;
• Active inflammatory conditions in the oral cavity due to causes other than inflammation resulting from third molar extraction surgery;
• Any radiologic finding (panoramic dental radiograph) that, in the investigator's opinion, may place the participant at risk if enrolled in the study.
• History or confirmed diagnosis of peptic ulcer disease, gastrointestinal disorders associated with nonsteroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding, or other active bleeding;
• History or confirmed diagnosis of acute or severe bronchial asthma;
• History or confirmed diagnosis of moderate to severe renal impairment, severe hepatic impairment, or severe cardiac impairment;
• Use of sedative medications (e.g., benzodiazepines) or hypnotic agents that cannot be discontinued during the prohibited medication washout period specified in the protocol;
• Chronic treatment with opioid medications.
• Participants with pre-existing respiratory conditions, such as chronic obstructive pulmonary disease (COPD), sleep apnea, or respiratory failure, or those receiving other central nervous system (CNS) depressants, such as benzodiazepines or other opioids;
• History or confirmed diagnosis of anaphylactoid reactions (e.g., urticaria, rhinitis, angioedema) associated with the use of analgesics.