So Acadia is moving like a freight-train through its Phase III trial in hope for FDA approval. I luckily got in somewhat early but eager to buy more. I am thinking it is time to re-up and go for another round as they seek approval for their Parkinson's Disease medication Pimavanserin. Here is the info from their website. Current trading is up 15.5% at 6.11 up 0.82 today alone. So look forward to approval soon and happy trading. If approved I see the stock going between the 9-11 point range. Results could be higher or lower but just a hunch as Parkinson's Disease patients do not react well to the anti-psychosis medication currently available.
Pimavanserin is a small molecule product candidate that we discovered and have advanced to Phase III development as a treatment for patients with Parkinson's disease psychosis. Pimavanserin can be taken orally and blocks the activity of the 5-HT2A receptor, a key serotonin receptor that plays an important role in the treatment of various psychiatric disorders. Parkinson's disease psychosis is a debilitating psychiatric disorder that occurs in up to 40 percent of patients with Parkinson's disease. The development of psychosis in patients with Parkinson's disease is associated with increased caregiver burden, nursing home placement, and increased mortality.
Currently there is no therapy in the United States approved to treat Parkinson's disease psychosis. Physicians may attempt to address this disorder initially by decreasing the dose of the dopamine replacement drugs, which are administered to patients to manage the motoric symptoms of Parkinson's disease. However, this approach is generally not effective in alleviating psychotic symptoms in most patients and is often associated with the significant worsening of motor function in these patients.
Despite substantial limitations, currently marketed antipsychotic drugs also may be used off-label to treat patients with Parkinson's disease psychosis. Because antipsychotic drugs block dopamine receptors, which may counteract the dopamine therapy used to manage the motoric symptoms of Parkinson's disease, these drugs are generally not well tolerated by patients with Parkinson's disease at doses required to achieve antipsychotic effects. Current antipsychotic drugs also are associated with a number of side effects, which can be especially problematic for elderly patients with Parkinson's disease. In addition, antipsychotic drugs have a black box warning for use in elderly patients with dementia-related psychosis due to increased mortality and morbidity. We believe that pimavanserin has the potential to be the first-in-class treatment for this disorder, which may effectively treat Parkinson's disease psychosis without impairing motor function, thereby significantly improving the quality of life for patients with Parkinson's disease.
We believe that pimavanserin has the potential to address a range of central nervous system indications with large unmet medical needs. Together with Biovail, we plan to leverage our Phase III program in Parkinson's disease psychosis to develop and commercialize pimavanserin for multiple neurological and psychiatric indications that are underserved by currently marketed antipsychotics, including psychosis in patients with Alzheimer's disease.
We are currently conducting a number of studies in our Phase III program with pimavanserin for Parkinson's disease psychosis, including two pivotal trials, an open-label safety extension study, and other NDA supporting studies.
We have completed a Phase II clinical trial in which pimavanserin demonstrated motoric tolerability and antipsychotic effects in patients with Parkinson's disease, and was safe and well tolerated in the study.
In addition, we have reported positive results from a Phase II clinical trial with pimavanserin as a co-therapy in schizophrenia. The results of this trial demonstrated several advantages of co-therapy with pimavanserin and a sub-maximal dose of risperidone, a commonly prescribed antipsychotic drug, including enhanced efficacy, a faster onset of antipsychotic action, and an improved side effect profile. We also have completed a proof-of-concept clinical study in which pimavanserin induced a significant increase in slow wave sleep in older healthy volunteers.
In other news here is a clip from earlier last week.
Acadia Pharma to slash 50% of workforce
Marketwatch Aug 5, 2008, 7:01 p.m. EST
(8:55 AM ET) BOSTON (MarketWatch) -- Acadia Pharmaceuticals /quotes/comstock/15*!acad/quotes/nls/acad (ACAD 6.15, +0.04, +0.66%) said Tuesday that it plans to slash about 50% of its workforce, bringing its headcount down to around 65 employees. The drug developer said that the restructuring will allow it to focus on its lead drug candidate pimavanserin, a treatment for psychosis associated with Parkinson's disease. The product is currently in Phase III testing. Acadia will also continue two early-stage drug development programs that are currently being funded by Allergan Inc. /quotes/comstock/13*!agn/quotes/nls/agn (AGN 54.65, -0.14, -0.26%) . Earlier Tuesday, Acadia reported a second-quarter loss of $18.3 million, or 49 cents a share, compared with a loss of $10.8 million, or 29 cents a share, for the same quarter last year. Revenue fell to $177,000 from $2.1 million, due primarily to the completion of two collaborative agreements and lower revenue from its Allergan partnership.