Neuroscience
The Food and Drug Administration (FDA) today announced its approval of this medication as a treatment for a common neurological complication of diabetes. From the press release:
FDA Approves Drug for Neuropathic Pain Associated With Diabetes
Today the Food and Drug Administration (FDA) announced the approval of Cymbalta (duloxetine hydrochloride) capsules for the management of the pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. Cymbalta received a priority review.
"Diabetes affect millions of Americans," said Dr. Lester M. Crawford, Acting FDA Commissioner. "With this new treatment we will hopefully be able to help relieve the pain associated with this terrible disease."
Diabetic peripheral neuropathy is a problem associated with long standing diabetes or poor glucose control. Peripheral neuropathy is the most common complication of diabetes mellitus, affecting up to 62% of Americans with diabetes. Diabetic peripheral neuropathy can manifest in a variety of ways but is usually characterized by burning, tingling, and numbing sensations beginning in the feet, and later affecting the legs and/or hands.
The safety and effectiveness of Cymbalta were established in two randomized, controlled studies of approximately 1074 patients. Although the mechanism of action is unknown, patients treated with Cymbalta reported a greater decrease in pain compared to placebo. In these trials, 58 percent of patients treated with Cymbalta reported at least a 30 percent sustained reduction in pain. In comparison, 34 percent of patients treated with placebo reported this magnitude of sustained pain reduction.
The most commonly reported side effects were nausea, dry mouth, constipation, and diarrhea. In some cases, patients experienced dizziness and hot flashes.
Cymbalta is manufactured by Eli Lilly and Company in Indianapolis, Ind.
- Fda Approves Multiple Sclerosis Drug, Ampyra (dalfampridine) Extended-release
From FierceBiotech: FDA approves Acorda's new MS drug January 22, 2010 — 4:49pm ET By John Carroll [snip] The FDA announced Friday afternoon that it has approved Ampyra (dalfampridine) extended-release tablets to improve walking in patients with...
- Progressive Inflammatory Neuropathy (pin)
From the CDC's Morbidity and Mortality Weekly Report (MMWR) on 31 January 2008: Investigation of Progressive Inflammatory Neuropathy Among Swine Slaughterhouse Workers --- Minnesota, 2007---2008 [snip] "This report summarizes an ongoing investigation...
- Risperdal (risperidone) And Pediatric Schizophrenia And Bipolar Disorder
An FDA press release from yesterday: FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages...
- Rasagiline And Parkinson's Disease
From the FDA on the 17th of May: FDA Approves New Treatment for Parkinson's Disease The Food and Drug Administration today approved Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson's disease. The drug is a monoamine...
- Strattera (atomoxetine) And Attention Deficit Disorder
A press release from the Food and Drug Administration (FDA):FOR IMMEDIATE RELEASE P05-65 September 29, 2005 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Issues Public Health Advisory on Strattera (Atomoxetine) for...
Neuroscience
Cymbalta and Diabetic Peripheral Neuropathy
The Food and Drug Administration (FDA) today announced its approval of this medication as a treatment for a common neurological complication of diabetes. From the press release:
FDA Approves Drug for Neuropathic Pain Associated With Diabetes
Today the Food and Drug Administration (FDA) announced the approval of Cymbalta (duloxetine hydrochloride) capsules for the management of the pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. Cymbalta received a priority review.
"Diabetes affect millions of Americans," said Dr. Lester M. Crawford, Acting FDA Commissioner. "With this new treatment we will hopefully be able to help relieve the pain associated with this terrible disease."
Diabetic peripheral neuropathy is a problem associated with long standing diabetes or poor glucose control. Peripheral neuropathy is the most common complication of diabetes mellitus, affecting up to 62% of Americans with diabetes. Diabetic peripheral neuropathy can manifest in a variety of ways but is usually characterized by burning, tingling, and numbing sensations beginning in the feet, and later affecting the legs and/or hands.
The safety and effectiveness of Cymbalta were established in two randomized, controlled studies of approximately 1074 patients. Although the mechanism of action is unknown, patients treated with Cymbalta reported a greater decrease in pain compared to placebo. In these trials, 58 percent of patients treated with Cymbalta reported at least a 30 percent sustained reduction in pain. In comparison, 34 percent of patients treated with placebo reported this magnitude of sustained pain reduction.
The most commonly reported side effects were nausea, dry mouth, constipation, and diarrhea. In some cases, patients experienced dizziness and hot flashes.
Cymbalta is manufactured by Eli Lilly and Company in Indianapolis, Ind.
- Fda Approves Multiple Sclerosis Drug, Ampyra (dalfampridine) Extended-release
From FierceBiotech: FDA approves Acorda's new MS drug January 22, 2010 — 4:49pm ET By John Carroll [snip] The FDA announced Friday afternoon that it has approved Ampyra (dalfampridine) extended-release tablets to improve walking in patients with...
- Progressive Inflammatory Neuropathy (pin)
From the CDC's Morbidity and Mortality Weekly Report (MMWR) on 31 January 2008: Investigation of Progressive Inflammatory Neuropathy Among Swine Slaughterhouse Workers --- Minnesota, 2007---2008 [snip] "This report summarizes an ongoing investigation...
- Risperdal (risperidone) And Pediatric Schizophrenia And Bipolar Disorder
An FDA press release from yesterday: FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages...
- Rasagiline And Parkinson's Disease
From the FDA on the 17th of May: FDA Approves New Treatment for Parkinson's Disease The Food and Drug Administration today approved Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson's disease. The drug is a monoamine...
- Strattera (atomoxetine) And Attention Deficit Disorder
A press release from the Food and Drug Administration (FDA):FOR IMMEDIATE RELEASE P05-65 September 29, 2005 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Issues Public Health Advisory on Strattera (Atomoxetine) for...