SEC Flags Safety, Efficacy Gaps in Troikaa's Rapid IV Paracetamol Bolus Proposal, Seeks More Data

Commonly expected adverse events such as facial flushing, transient hypotension, arrhythmias, and liver toxicity (measured via international normalized ratio) were not reported in the trial. Since these effects are known to occur with IV paracetamol, the committee noted that the firm must clarify the absence of these adverse events with relevant data and additional study evidence.

The indications applied for, including the management of mild to moderate pain, moderate to severe pain with adjunctive opioid analgesics, and treatment of fever, were considered not supported by the presented clinical trial data, published literature, or supplementary documentation.

Practical concerns were also raised regarding the availability of suitable 20 ml syringes for administering the proposed concentrated formulation and ensuring controlled flow rate during its rapid intravenous administration.

In conclusion, the committee advised Troikaa Pharmaceuticals to submit additional data, scientific literature, and study protocols to address the above observations. The proposal was not granted approval at this stage.

Paracetamol, a widely used antipyretic and analgesic, is commonly administered intravenously for acute pain and fever. While standard IV formulations require longer infusion times, this new concentrated bolus format proposes quicker administration but raises regulatory concerns regarding safety and practical use.