Medicines (Rx) 
Oraphine® 60mg Soft Capsule
Oraphine® 60mg Soft Capsule
Indications: acute moderate to severe pain
Drug permit license no. 060459
Active pharmaceutical ingredients
Nalbuphine Hydrochloride 60 mg.
Mechanism of action
- Partial mu-opioid receptor (MOR) antagonist / Kappa-opioid receptor (KOR) agonist to achieve analgesic effect.
- The analgesic effect is comparable to Morphine.
Dosage and Administration
Oraphine® 60mg Soft Capsule should be taken after a meal. Recommend dosage for adults is 1 capsule each time and 3 times a day up to a total of 3 days; the first dose on the first day is 2 capsules.
Packaging
ALU-PVC blister pack of 10 capsules.
Storage
The product should be stored at 25℃, the allowable temperature range is 15°C〜30°C. Please store it in the box and take it out only before use. Please avoid excessive sunlight exposure.
Description
Nalbuphine hydrochloride is a synthetic narcotic agonist-antagonist, analgesics of the Phenanthrene range. Its chemical structure is related to the widely used narcotic antagonist Naloxone and the potent narcotic analgesic Oxymorphone. Oraphine® 60mg Soft Capsule is an oral softgel for oral use only; each capsule contains 60 mg of Nalbuphine hydrochloride.
Clinic pharmacology (according to medical literature)
Nalbuphine hydrochloride is a potent analgesics. Its analgesic potency is measured in milligrams, and its effectiveness is similar to that of Morphine. Nalbuphine hydrochloride is an analgesic of kappa agonist/partial mu antagonist.
Clinical efficacy results (Pivotal Clinical Trial)
- Primary endpoint
The Area Under Curve (AUC1-48) of Visual Analogue Scale(VAS score) from 1 to 48 hours after surgery was analyzed and compared by ANOVA. The AUC1-48 values of the VAS score of Oraphine® 60mg Soft Capsule group and the placebo were 149.2 and 179.6, respectively. There was a significant difference between these two (P = 0.0301).
- Secondary endpoints 1
Intramuscular injection of Diclofenac: The result analysis of Intention-to-Treat (ITT) population showed that compared to the placebo, the percentage of intramuscular injection of Diclofenac within 2 days after surgery was much lower in the Oraphine® 60mg Soft Capsule group (66.0% vs. 92.5%, P=0.0009).
- Secondary endpoints 2
Time from the end of surgery to the first intramuscular injection of Diclofenac was analyzed for the subjects. Compared to the placebo, the Oraphine® 60mg Soft Capsule group had a longer median time for the first intramuscular injection of Diclofenac (11 hours vs. 7 hours, P=0.0042).