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Acasti Pharma announces preliminary resulst in study of GTX-101
The Fly

Acasti Pharma announces preliminary resulst in study of GTX-101

Acasti Pharma announced that preliminary topline results for its single-dose, pharmacokinetic bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug in the U.S., bupivacaine subcutaneous injectable, met all primary outcome measures for the study. The final clinical study report is anticipated to be received by the Company in the first half of 2023. This PK study was the next step in the proposed 505(b)(2) regulatory pathway for GTX-101 and provides important information on the dose and dosing frequency in humans for future planned clinical studies. Primary outcome measures and their definitions include: The median time to reach the maximum concentration of bupivacaine in plasm following GTX-101 single-dose topical applications of 50, 100 and 200 mg ranged between 18 to 24 hours depending on dose, while the median Tmax following the subcutaneous injection of 10 mg of bupivacaine was only 23 minutes. This finding suggests that the bupivacaine delivered by GTX-101 remains in the skin for a long period of time, potentially inducing prolonged analgesic effect in the sprayed area. The exposure to bupivacaine based on Cmax and AUC following GTX-101 topical application as a single-dose of 50, 100 and 200 mg, increased with increasing dose. This was predictable and expected. The systemic exposure to bupivacaine following a 200mg dose of GTX-101 was: Approximately 29-fold less than a single subcutaneous dose of 10mg of bupivacaine based on Cmax and, Approximately 6-fold less than a single subcutaneous dose of 10mg of bupivacaine based on AUC. These results are predicted to correspond to an increased safety margin for GTX-101 with regards to toxicity risk. The mean half-life following GTX-101 single-dose topical application of 50, 100 and 200 mg ranged between 24 to 37 hours depending on dose, suggesting a slow elimination and potentially long duration of effect, while the mean Thalf following the subcutaneous injection of 10 mg of bupivacaine was only 8 hours. Adverse events judged as related to the study drug by the investigator were: Following GTX-101 topical application: headache and numbness at the sprayed area, and Following bupivacaine subcutaneous injection: dizzines and nausea.

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