A highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors, it is approved in countries around the world as an adjunctive therapy
for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
With this US FDA approval, the adults and adolescents aged 16 years and older with POS in the US can now be initiated on BRIVIACT as monotherapy or adjunctive therapy
A recent general advice l etter from the US FDA stated it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy
for the treatment of POS to their use as monotherapy for the treatment of POS, upon which, UCB was able to support its BRIVIACT monotherapy submission with brivaracetam clinical trials data in more than 2,400 adult patients with POS.
LATUDA is indicated for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy
with lithium or valproate in adults.
The FDA policy has determined that it is acceptable to extrapolate safety and efficacy of AEDs approved as an adjunctive therapy
for the treatment of partial-onset seizures to their use as monotherapy for the treatment of partial-onset seizures.
UCB has received approval from the FDA for BRIVIACT (brivaracetam) as adjunctive therapy
for the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.
announced that the FDA has approved Fycompa (perampanel) CIII for adjunctive therapy
in the treatment of primary generalized tonic-clonic (PGTC) seizures, one of the most common and severe forms of generalized seizures with a high incidence of morbidity and mortality.
This study is the first trial investigating the efficacy and safety of adjunctive therapy
with curcuminoids-piperine combination in patients with metabolic syndrome receiving standard treatment.
According to doctors, it is indicated as adjunctive therapy
to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Type IIa and IIb).
The FDA Investigational Device Exemption (IDE-15140) allows Arteriocyte and its clinical partners to initiate evaluation of autologous platelet gel (APG) (using the Magellan Autologous Platelet Separator technology) as an adjunctive therapy
for autologous skin grafting in patients with thermal injuries.
Is oral administration of Chinese herbal medicine effective and safe as an adjunctive therapy
for managing diabetic foot ulcers?
In a unanimous vote, a federal advisory panel agreed that the antiepileptic drug ezogabine had been shown to be effective as adjunctive therapy
for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention.