- The FDA has approved expanded labeling for Cumberland Pharmaceuticals Inc's CPIX Caldolor, an intravenously delivered formulation of ibuprofen, to now include use in pre-operative administration.
- The non-narcotic pain reliever can now be administered just before surgery to enable patients to wake up from their procedure in significantly less pain.
- Supporting this expanded use of Caldolor, a study of orthopedic surgical pain confirmed the significant pain reduction when the product was administered every six hours (started pre-operatively) with supplemental morphine available on an as-needed basis.
- A total of 185 patients were randomized and treated with either Caldolor 800 mg or placebo and morphine.
- Efficacy was demonstrated as a statistically significant greater reduction in pain intensity over 24 hours postoperatively for patients treated with Caldolor than those receiving placebo.
- Caldolor is indicated for pain management and fever reduction.
- It was the first FDA-approved intravenous therapy for fever.
- See here Benzinga's Full FDA Calendar.
- Price Action: CPIX shares are up 111.4% at $4.65 during the premarket session on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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