Currently there are only two FDA approved intravenous (IV) analgesics that cannot be given preoperatively and they are IV acetaminophen and 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.
RH Nanopharma has developed a proprietary IV nanoformulation (RHN-002) to treat acute postoperative pain and other orphan disease related pain syndromes. Our Phase 1 study is soon to be started in healthy volunteers and has an open IND with FDA approval. Since RHN-002 has no increased bleeding risks and no reports of increased cardiac toxicity nor gastrointestinal toxicity, it is poised to be a safer replacement for IV acetaminophen and IV ketorolac in all postoperative patients, including those high risk patients. RHN--002 is in the FDA approved Phase 1 trial stage in healthy volunteers and we anticipate it to be a opioid sparing analgesic, something sorely needed now more than ever in the past.