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August 20, 2007
Two New Promising Medications For Treatment of Schizophrenia
Read more... Schizophrenia Medications in Development
Two new drugs being developed by Acadia Pharmaceuticals, will hopefully help many people suffering from psychosis, especially schizophrenia. One drug, pimavanserin is being created as a co-therapy drug to be used in co-ordination with other antipsychotics. While ACP-104 is being developed as an antipsychotic, it is also hoped to have cognitive enhancing features; therefore treating two of the main problems associated with schizophrenia. Although these drugs look promising, and are already into their phase II trails, its important to understand that many drugs are still in their FDA testing phase and may never become available for sale to the public if they don't pass these safety and effectiveness tests (last month a medication called bifeprunox was rejected by the FDA because it was not very effective). Here is some information on medication development and the process of being FDA approved.
The following information is from a recent presentation from the president of Acadia pharmaceuticals - and as such it represents a very biased view of their medication as he is in the business of selling medication. We encourage a healthy level of skepticism as you read the information, and ultimately the benefits and side effects of the drug will (if it comes to market) only be known after long term testing by independent government-funded research projects.
Pimavanserin is a drug in development for treatment of different types of psychoses, including schizophrenia. Until recently it was called ACP-103. Pimavanserin works on the neurotransmitter serotonin, by blocking the 5-HT2A receptor; or in other words, being a serotonin antagonist. Serotonin is not the traditional neurotransmitter focus for antipsychotics, but has been very successful in drugs that treat depression and anxiety.
Pimavanserin is said to have a long duration of action, meaning its effects last for a long period of time. This can be beneficial in decreasing the amount of doses a patient would have to take. Current research has also shown it to be very safe. Pimavanserin is going to be marketed for the treatment of schizophrenia, and parkinsons psychosis, or psychosis NOS (not otherwise specified). But pimavanserin is not a stand alone drug, it is being development as an adjunct drug to be combined with the current effective antipsychotics. The hope is that adding this drug proves better by decreasing side effects and risks, while increasing efficacy.
In the last phase II study, which included over 400 participants suffering from acute psychosis, researchers found great results with pimavanserin. The participants were treated for 42 days, with 5 different treatments, and the results were measured with the PANSS scale (Positive and Negative Symptoms Scale--the commonly used measure for psychosis). The drug proved to have very powerful antipsychotic effects on the participants. They found that it was especially beneficial when combined with another antipsychotic. They looked at it with risperidone, and Haldol; both showed promise for using pimavanserin as a co-therapy drug.
The study also showed that when pimavanserin was combined with risperidone, it sped up the time for which patients began to benefit from the drugs. After only 2 weeks, 60% of the participants had begun responding to the treatment. Meaning, the drug managed symptoms faster. Whats really interesting is that when studying the effects of higher doses of risperidone alone, they found it took almost five full weeks to get a similar response in the participants. This is important because it shows that combining pimavanserin with another antipsychotic may decrease the amount of time for someone to rehabilitate. For those in hospitals, this means significantly lowering fees associated with hospital stays, because stays may be a lot shorter.
Probably the most beneficial findings were in relation to the decrease in side effects. Current antipsychotics may increase metabolic syndrome, weight gain, and other physiological health problems. They found 50% less weight gain in the pimavanserin risperidone combination than with a standard dose of risperidone alone.
Currently, there are many plans to continue studying pimavanserin for the treatment of schizophrenia. Researchers are beginning to plan for phase III drug trails and hope to get it FDA approved shortly thereafter. The creators of pimavanserin believe it will become a great adjunct drug to be applied to other antipsychotic drugs. By adding pimavanserin to the treatment, they may be able to increase efficacy and decrease side effects.
ACP-104 is being created as a stand-alone drug for treatment of schizophrenia. And because schizophrenia can show decreased cognitive functioning, the hope is that this drug, ACP-104, will limit the cognitive deficits by providing patients with cognitive benefits.
Certain patients who were gaining cognitive improvements while on clozapine motivated the development of ACP-104. Clozapine, when metabolized quickly, generated the metabolite ACP-104, which can enhance cognition by stimulating the muscarinic m1 receptor, which is a receptor for the neurotransmitter acetylcholine. Not only does ACP-104 work as a cognitive enhancer, it also has the ability to perform as an antipsychotic; a combination which sounds like a dream to those with schizophrenia.
So far, studies have found ACP-104 safe in 2-week tails. What’s more intriguing is that during the 2 weeks, participants were noticing benefits of the drug. This means they saw decrease in psychoses in some participants as early as 2-weeks into use of the drug. The drug is still early into the phase II trails. And they are now looking at large samples of participants being treated for six weeks, and measuring their symptoms with the PANSS.
Both drugs are not going to be available in the next year, but are two promising treatments that may revolutionize schizophrenia treatment. Acadia continues its drug trails and hopes to gain FDA approval after all phases are complete. These are definitely two drugs that are worth watching for updates
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Posted by Michelle Roberts at August 20, 2007 05:34 PM
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