Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACP-044 Dose A · 1 trial · 2 indications
Pain (efficacy) assessments were recorded hourly (±15 minutes) for a 12-hour interval on Day 1 beginning immediately prior to the fifth dose (time 0) administered in the study. Pain assessments were continued every 3 hours during the subsequent 12 hour interval, and then every 6 hours thereafter until 72 hours, then once daily in the morning until the follow-up clinical visit. Pain assessments were also obtained immediately prior to the administration of rescue medication. A 0 to 10 Numeric Rating Scale of Pain Intensity (NRS) was used to assess the subject's pain. Subjects were asked: "Please describe your foot pain at the present time from 0 to 10 where "0" means "no pain at all" and "10" means "the worst pain imaginable." The area under the curve is generated using the following timepoints beginning immediately prior to the fifth dose (time 0): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24 hours.
| Arm | Type | Description |
|---|---|---|
| Drug - ACP-044 Dose A | EXPERIMENTAL | ACP-044 Dose A |
| Drug - ACP-044 Dose B | EXPERIMENTAL | ACP-044 Dose B |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| ACP-044 Dose A | DRUG | Oral dose of ACP-044 Dose A |
| ACP-044 Dose B | DRUG | Oral dose of ACP-044 Dose B |
| Placebo | DRUG | Oral dose of placebo |
Inclusion Criteria: * Male or female ≥18 and \<60 years of age at the time of Screening * Has a body mass index (BMI) \<40 kg/m2 * Able to understand and provide signed informed consent * Able to complete subject-reported outcome measures * Is in need of a primary unilateral, first metatarsal bunio...
ACP-044 Dose A is an investigational small molecule being developed by ACADIA Pharmaceuticals Inc. for the treatment of acute postoperative pain. It is a Phase 2 candidate that has been studied in a placebo-controlled trial following bunionectomy surgery. It is not an approved product.
ACP-044 Dose A is being developed for acute postoperative pain, specifically pain following bunionectomy surgery. The Phase 2 program evaluated it in adults aged 18 years and older in the United States. Acute postoperative pain is the only indication studied for this candidate.
ACP-044 Dose A is being developed by ACADIA Pharmaceuticals Inc., which trades on the Nasdaq under the ticker ACAD. ACADIA is the sponsor of the clinical program for this investigational pain candidate.
ACP-044 Dose A is in Phase 2 development. Its single Phase 2 trial has been completed, and no active trials are currently listed. The candidate remains investigational and has not been approved by the FDA for any indication.
ACP-044 Dose A was studied in one Phase 2 trial, NCT04855240, titled Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy. The trial was completed, enrolled 239 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.