Iroko Pharmaceuticals presented results from two Phase 3 studies of its SoluMatrix, a nonsteroidal anti-inflammatory drug (NSAID) portfolio, for Tivorbex (indomethacin) and Zorvolex (diclofenac) at the American Pain Society Annual Meeting.

The Phase 3 study evaluating Tivorbex, assessed opioid rescue medication usage in 462 adult patients experiencing significant post-surgical acute pain. Patients were randomized to receive either Tivorbex 20mg three times daily, Tivorbex 40mg twice daily or three times daily, celecoxib 400mg loading dose followed by 200mg twice daily, or placebo. In patients with post-surgical pain of this magnitude, a high proportion of patients in all study arms required additional rescue analgesia, hydrocodone/acetaminophen or oxycodone/acetaminophen, over the 48 hours following randomization.

Results showed the following:

  • About half as many opioid-containing rescue medication tablets were used in the Tivorbex arms compared to the placebo group over 48 hours.
  • Patients randomized to the 40mg of Tivorbex three times daily and twice daily treatment arms used an average of 2.7 tablets of rescue medications; the Tivorbex 20mg three times daily group used an average of 3.0 tablets, the celecoxib group used an average of 3.1 tablets, and patients in the placebo group used an average of 5 tablets.
  • The time to first use of rescue medication, measured following the start of treatment with either Tivorbex or placebo, occurred later on average in the Tivorbex 40mg three times daily, 40mg twice daily and celecoxib 200 mg twice daily groups compared with placebo. The difference was statistically significant for the Tivorbex 40mg three times daily group (P=0.008) compared to placebo.

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An analysis of the pivotal Phase 3 Zorvolex trial assessed a number of patient reported outcomes and quality of life measures including Patient Global Impression of Change (PGIC) and Medical Outcomes Survey Short Form 36 (SF-36), version 2.

Following 12 weeks of treatment:

  • The overall differences in PGIC compared with placebo were significant in the Zorvolex 35mg three times daily (P<0.0001) and twice daily (P=0.0008) treatment groups.
  • Two-thirds of patients receiving Zorvolex 35mg three times daily (P<0.0006) and half of the patients receiving Zorvolex 35mg twice daily (P=0.0071) reported PGIC as “very much” or “much” improved relative to placebo.
  • Patients treated with Zorvolex 35mg three times daily reported statistically significant improvements in 5 SF-36 domains, 4 of which were clinically meaningful (≥ Minimally Clinical Important Difference). These included physical functioning, role physical, bodily pain and social functioning.

Both Zorvolex and Tivorbex are already approved for mild-to-moderate acute pain and are developed using proprietary SoluMatrix Fine Particle Technology. This enables the active ingredient to be available as submicron particles resulting in faster dissolution. A supplemental New Drug Application (sNDA) for Zorvolex for the treatment of osteoarthritis (OA) pain was accepted for review by FDA in January 2014.

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