On April 18, Acadia Pharmaceuticals Inc. (ACAD) shared that its acute postoperative pain therapy trial did not meet its primary endpoint. The disappointing news caused ACAD stock to plunge down by a further 6.34% in the pre-market. The stock was already trading in the red with a loss of 4.52% during the regular session. Thus, with the further decline pre-market, the stock then reached a value of $20.99 per share, on Tuesday.
ACAD’s ACP-044 Trial Results
On Monday, the company announced top-line results from the Phase 2 study of ACP-044. ACP-044 is a non-opioid investigational drug currently under development for acute and chronic pain treatment.
The study was evaluating the efficacy and safety of the therapy for the treatment of acute postoperative pain following bunionectomy surgery. Two doses of ACP-044; 1600 mg once daily and 400 mg four times daily were being evaluated against a placebo. The primary endpoint of the trial was a comparison of cumulative pain intensity scores over 24 hours against a placebo.
While the once-daily group completely failed to meet the primary endpoint, the other group did show a slight favorite on the endpoint. But the numerical trends while being better than the placebo were still not statistically significant at 48 and 72 hours.
Additionally, ACO-044 is currently being evaluated in a study on osteoarthritis.
Central Nervous System therapeutics include therapies for pain management, dementia, Alzheimer’s, Parkinson’s, Multiple Sclerosis, and other disorders. The global CNS therapeutics market is forecasted to grow at a CAGR of 9.05% to reach $168.43 billion by 2028 from $84.24 billion in 2020.
The frequency of mental illness and life-style related CNS disorders is increasing day by day. Moreover, rising awareness regarding psychiatric diseases and the growing elderly population are also contributing to the growth of the market. Pain management being an important part of the market is largely an unmet need. Most of the existing treatments for pain management include addictive therapies like opioids which come with their own share of drawbacks.
ACAD’s Analysis and Outlook
After resubmitting sNDA for pimavanserin for Alzheimer’s psychosis to the FDA, ACAD is now planning n submitting NDA for trofinetide for Rett syndrome this year. While the ACP-044 failed to show benefit in acute pain management study, its study in osteoarthritis is ongoing. The company expected the study to be completed in H1 2022.
For fiscal 2022, the company expected NUPLAZID net sales to be $510-$560 million with R&D expenses of $355-$375 million. Furthermore, SG&A expenses for the year are projected to be $360-$380 million.