Acadia wins FDA approval for first drug to treat Parkinson's disease psychosis
- Acadia Pharmaceutical's treatment for Parkinson's disease psychosis won approval from the Food and Drug Administration on Friday, giving Parkinson's patients an alternative to off-label antipsychotics for treatment of the condition.
- Nuplazid (pimavanserin) is now the first drug specifically approved to treat the hallucinations and delusions that up to 50% of all Parkinson's patients experience. However, the FDA will require Nuplazid to carry a black-box warning for the increased risk of death in elderly patients taking the drug.
- The company expects to launch Nuplazid in June and early forecasts have estimated sales of $1.41 billion by 2020.
For physicians and patients, Nuplazid could address a longstanding unmet medical need. Despite the large selection of antipsychotics available for the treatment of psychosis, physicians have long struggled with how to treat patients with Parkinson's disease psychosis (PDP).
Parkinson's is a neurodegenerative brain disease in which the brain slowly stops producing dopamine, a neurotransmitter associated with smooth, fluid movement. Standard therapies for the condition aim to replace the lost dopamine, thereby alleviating the disease's characteristic tremors and muscle rigidity.
However, many antipsychotics function by targeting dopamine, making treatment of both pyschosis and Parkinson's standard symptoms a careful balancing act. Nuplazid, on the other hand, selectively targets 5-HT2A receptors -- which are thought to be linked to PDP -- while avoiding interfering with dopamine therapies.
"“Through its novel and selective mechanism of action, Nuplazid is a breakthrough treatment that works in a whole new way - treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson’s psychosis patients," said Michael Okun, medical director at the National Parkinson Foundation
In a recent six-week trial, Nuplazid demonstrated superiority to a placebo in reducing the frequency and severity of psychosis symptoms without impairing motor function.
Acadia CEO Steve Davis was bullish on Nuplazid, calling the drug a "major medical advancement for patients with Parkinson’s disease psychosis".
Acadia is also developing pimavanserin (Nuplazid's generic name) for treatment of psychosis tied to Alzheimer's disease and for schizophrenia. These indications would be for a broader patient population, giving the drug a higher upside if Acadia can prove efficacy in treating the conditions.
Nuplazid will be priced on the high end, at $13,500 per patient per year, according to an analyst cited by Reuters. Coupled with the required black-box warning, this could be a factor in slowing uptake. But many so-called "atypical anti-psychotics" carry the boxed warnings and Nuplazid's pole position in the market should help it win coverage from insurers.
After early gains in Monday trading, Acadia stock dipped by as much as 5% following a call with investors.