Saphris: New FDA Approved Drug for Schizophrenia & Bipolar Disorder
The U.S. Food and Drug Administration (FDA) has recently given its thumbs up on Saphris (asenapine) as a new drug for adults with schizophrenia and bipolar disorder.
People suffering from schizophrenia and bipolar disorder have just been given another treatment option for their condition with the recent approval of a new drug. The U.S. Food and Drug Administration (FDA) has recently given its thumbs up on Saphris (asenapine) as a new drug for adults with schizophrenia and bipolar disorder. This drug is another important offering of Schering-Plough, which acquired the Netherlands-based pharmaceutical company Organon in March 2007.
Schizophrenia and Bipolar Disorder Defined
Schizophrenia is defined by the World Health Organization (WHO) as “a severe mental disorder, characterized by profound disruptions in thinking, affecting language, perception, and the sense of self.”
The most common symptoms seen in people with schizophrenia include hallucinations, having false beliefs (delusions) and paranoia. These thoughts may be extremely terrifying to the patient and can lead to fearfulness, withdrawal, agitation, or violence.
Bipolar disorder, also called manic-depressive disorder, is defined by the National Institute of Mental Health (NIMH) as “a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks.”
FDA Approval of Saphris for the Treatment of Schizophrenia and Bipolar Disorder
In a news release issued by the FDA, dated Aug. 14, Thomas Laughren, M.D., director of the Division of Psychiatry Products in the agency’s Center for Drug Evaluation and Research, said that mental disorders, such as schizophrenia and bipolar disorder “can be devastating to patients and families, requiring lifelong treatment and therapy.” According to him, drugs that are effective can help those who suffer from mental disorders “live more independent lives.”
Saphris belongs to a class of drugs known as atypical antipsychotics. This group of drugs carries FDA’s most powerful warning written in a prominent box. This warning calls the attention of clinicians to the increased risk of death related to off-label use of these drugs as treatment for behavioral disorders in the elderly suffering from psychosis associated with dementia. It should be noted that the FDA did not approve the use of Saphris in this group.
The approval of Saphris for the treatment of schizophrenia was based on three short-term placebo-controlled and active drug-controlled clinical trials investigating the drug’s efficacy against this mental disorder. In two trials, Saphris showed greater efficacy against an inactive pill (placebo) in controlling the symptoms of schizophrenia.
On the other hand, the efficacy of Saphris in treating bipolar disorder was investigated in a couple of short-term placebo-controlled as well as active drug-controlled clinical trials. In these trials, Saphris also performed better than placebo in the treatment of bipolar disorder-associated symptoms.
Adverse Reactions Noted
Patients in clinical trials looking into the efficacy of Saphris as schizophrenia treatment reported mostly of akathisia or the feeling of “inner” restlessness leading to the inability to sit still or remain immobile, oral hypoesthesia or reduced oral sensitivity, and drowsiness.
In clinical trials using Saphris as treatment for bipolar disorder, the most common adverse reactions reported by patients were dizziness, drowsiness, akathisia and other movement disorders and weight gain.
U.S. Approval and Availability
The approval of this new drug has paved a wider way for the drug-based therapy of schizophrenia and bipolar disorder in adults. Thomas P. Koestler, Ph.D., executive vice president and president of the Schering-Plough Research Institute, said that they are very delighted with the recent approval of Saphris in the United States, which according to him, “represents an important new choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment.”
Saphris, a significant addition to the product line of Schering-Plough, and serves as the first to gain U.S. approval after the company’s merger with Organon, is expected to be made available to about 2 million Americans with schizophrenia and 10 million Americans with bipolar disorder, during the last quarter of 2009.
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ken bultman | Aug 20, 2009 | Reply
Informative article and my first encounter with the new medicine. I hope it is effective for those requiring it. I do believe that bi-polar is over -diagnosed and often used as an excuse for bad behavior.
Christine Ramsay | Aug 20, 2009 | Reply
The new drug certainly sounds promising. I hope it helps bi-polar sufferers. A very good article.
Christine
CHAN LEE PENG | Aug 20, 2009 | Reply
This sounds good new and gives hope to the sufferer. Great article and have my liked it.
Jenny Heart | Aug 20, 2009 | Reply
Good luck to this suffers. May they find answers. Like it!
nobert soloria bermosa | Aug 20, 2009 | Reply
good news for those who are suffering from these ilnesses
Lady Sunshine | Aug 20, 2009 | Reply
Very informative article, Melody.
Joe Dorish | Aug 20, 2009 | Reply
Good news for those who will be helped by the drug.
PR Mace | Aug 20, 2009 | Reply
Thank you for this article. Our son has bipolar disorder and as long as he takes him medication he does well. It is a terrible mental illness for the person that has it and their families. I know first hand.l
Moses Ingram | Aug 20, 2009 | Reply
I have a friend with bipolar disorder and know it can be terrible. I pray that this drug works. Thanks for such an informative article.
papaleng | Aug 20, 2009 | Reply
A very pleasant news for those people afflicted with bipolar disorder. This drug would surely of help.
S.Rubeck | Aug 20, 2009 | Reply
Very well written and informative article. Of course though, yet another medication with the ‘weight gain’ side effect. That always does wonders for ones mood and self image. I do hope this medicine works for those with schitzophrenia and bipolar who need it. “like it”
fishfry aka Elizabeth Figueroa | Aug 20, 2009 | Reply
I can only hope that this medication does work. I know people with Bi polar and it is not at all pretty, as well as schitzophrenia. Let us hope and pray that this is one of the better medications out there.
Monica Sappleton | Aug 21, 2009 | Reply
Very well done Melody, excellent research, and presentation. This promising new drug may just be the answer to hundreds of people suffering from this disorder. Thanks for this good information.
Monica.
Eunice Tan | Aug 22, 2009 | Reply
Great information. Hope it will bring huge good impact
Poetic Enigma | Aug 23, 2009 | Reply
Very informative article,
Thanks for sharing!
Mr Ghaz | Aug 23, 2009 | Reply
Well done!!..a very helpful and highly informative article..Thanks a lot for sharing this great tips. keep it up sis.
Ruby Hawk | Aug 23, 2009 | Reply
It will be wonderful news for those suffering these conditions. I hope it is the new miracle drug.
CutestPrincess | Sep 1, 2009 | Reply
Brilliantly written article, good information.
Leonardo da Vinci E. | Sep 3, 2009 | Reply
Unfortunantly the drug companies tend to place an impossible price on these products to maximize profits……also, if weight gain is a side effect that would be something to look at carefully.
chaoco | Jun 5, 2010 | Reply
I have schizophrenia and have tried multiple drugs and am mostly allergic to anti psychotics so my response be prerogative. I currently take 1200 lithium, flexiril for neuralgia pain tardive dyskenisia and grimace facial muscle pain, metoprolol tartrate for hypertension due to inflammation or other, and ambien for sleep terror disorder. I have constant auditory and visual hallucinations with two other personalities that try to takeover my main personality for use of my day to day body and I have found that Ambien and other hypnotic sedatives work better than lithium and all other drugs I have taken, I take ten mg ambien and if I stay awake it causes the voices to fall asleep and become much less responsive and much less hallucinatory, though it increases the persistent sexual arousal syndrome they cause as they move around but even this is less in all at its peak. If they could develop a sedative hypnotic i could take during the daytime that does not cause visual hallucinations I would take it and it would be seventy five percent effective rather than the dull twenty five percent effectiveness of lithium and other antipsychotics that do not cause (in some cases) even worse symptoms than the schizophrenia bacteria by itself without any chemical compounds at all.
chaoco | Jun 5, 2010 | Reply
Sounds like novane, when I took this i needed to bash my head into the wall to lessen the restlessness, (not literal) but works to stop hallucinations,