Currently there are only two FDA approved IV analgesics that cannot be given preoperatively and are IV acetaminophen and IV ketorolac.
IV acetaminophen has little to no clinically relevant anti-inflammatory effects and is often given at the conclusion or near the conclusion of the operation, well after the inflammation/damage to the skin and inner organs has occurred.
IV ketorolac has many “black box” warnings such as gastrointestinal bleeding, increased risk of cardiac events (heart attack) and generalized increase in bleeding.
This makes IV ketorolac a very risky medicine for the patient and surgeon.
We at RH Nanopharma are working on an IV nanosuspension of salsalate. We expect the animal studies to be completed by end 2nd qtr 2018 and first in human studies as early as beginning of 4th qtr 2018.
Since salsalate is as as safe as “placebo” in carefully designed and controlled head to head studies, and has no increased bleeding risks and no reports of increased cardiac toxicity nor gastrointestinal toxicity, IV Nanosal is poised to be a very good replacement for these two and only 2 FDA approved analgesics.
IV Nanosal is being formulated to be administered as a small bolus to be quickly injected preoperatively to reduce the postoperative inflammation and pain.
We also expect IV Nanosal to receive very favorable and rapid review by the FDA as it is also hoped to be a opioid sparing analgesic, something sorely needed now more than ever in the past.