Posts Tagged ‘Food and Drug Administration’

Aimmune Therapeutics announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AR101, an oral immunotherapy for children and adolescents 4–17 years of age who are allergic to peanuts.

Aimmune Therapeutics recently announced positive results of ARC001, its randomized, double-blind, placebo-controlled Phase 2 study of AR101 for desensitization treatment of peanut allergy. Results demonstrated that 100% of patients who completed the active treatment regimen (n=23) tolerated exposure to a cumulative amount of at least 443mg of peanut protein, and 78% of those patients tolerated exposure to a cumulative amount of 1,043mg of peanut protein.

AR101 is a complex mixture of naturally occurring proteins and pharmaceutical-grade inactive ingredients designed to enable the dosing of consistent amounts of peanut protein with well-defined concentrations of peanut allergens. Patients ingest AR101 mixed with a common, age-appropriate food.

The company plans to initiate a Phase 3 confirmatory registration trial of AR101 for the desensitization treatment of peanut allergy in children and adults.

For more information visit Aimmune.com.

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Researchers from Louisiana State University have found that blueberries may be effective in the treatment for post-traumatic stress disorder (PTSD). Findings from the study have been presented at the Experimental Biology Meeting in Boston, MA.

Presently, the only therapy approved by the Food and Drug Administration (FDA) for PTSD is selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. Study authors have previously shown that SSRIs increase the level of serotonin (5-HT) and norepinephrine, and that the increased norepinephrine be a possible reason for the reduced efficacy of SSRI therapy.

For this study, the team studied the ability of blueberries to modulate neurotransmitter levels in a rat model of PTSD. Some of the rats received a 2% blueberry-enriched supplement diet and others received a control diet. A third control group consisted of rats without PTSD and received a standard diet without blueberries. Scientists used high-performance liquid chromatography to to measure monoamines and related metabolite levels.

Rats with PTSD who did not receive blueberries showed a predictable increase in 5-HT and norepinephrine level compared with the control group. But rats with PTSD that received blueberries showed a beneficial increase in 5-HT levels with no impact on norepinephrine levels, which suggest that blueberries can alter neurotransmitter levels in PTSD. More studies are needed to understand the protective effects of blueberries and its potential target as a treatment for PTSD.

http://www.empr.com/benefits-of-blueberries-for-post-traumatic-stress-disorder-explored-in-study/article/405810/