After reporting the regulatory approval of two new dosing formulations for the company's one and only drug Nuplazid, shares of Acadia Pharmaceuticals (NASDAQ:ACAD), a commercial-stage biopharma focused on diseases of the central nervous system, rose as much as 13% in early morning trading on Friday. Shares have since pulled back a bit but were still up about 7% as of 10:11 a.m. EDT on Friday.
Acadia announced today that the FDA has approved two new dosing formulation of its Parkinson's disease psychosis drug Nuplazid. The two new capsules are a 34 mg and 10 mg formulation of the drug. The new 34 mg dosing option is designed to replace the two 17 mg tablets that many current patients take. The 10 mg version is designed to provide patients with a lower dosage version of the drug.
Dr. Joseph Friedman, a physician from Butler Hospital and Brown University, offered investors the following commentary about the approval:
The replacement of two 17 mg tablets with a single 34 mg capsule provides a simpler and more straightforward approach for the 34 mg once daily NUPLAZID dosing regimen, while also reducing the overall pill burden for my Parkinson's disease patients who often also take multiple other medications concomitantly.
The new capsules are expected to be available for sale by the middle of August.
2018 has been a rough year for Acadia's shareholders, so it's nice to see some positive news come from the company for a change. Offering healthcare providers new dosing options could help to spur additional usage of the drug and help Nuplazid reach blockbuster status.
However, the big question for Acadia's investors moving forward is how the FDA will respond the to reports of safety issues related to the use of Nuplazid. That question remains unanswered, so I continue to believe caution is warranted.