The phase two study is a multicentre, randomised, double-blind, placebo-controlled three-arm study to evaluate the safety and tolerability of multiple oral doses of REL-1017 25mg and 50mg as adjunctive therapy
in the treatment of patients diagnosed with major depressive disorder.
Food and Drug Administration approved multiple applications for first generics of Lyrica for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy
for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury, the agency announced today.
In conjunction, the paediatric exclusivity determination is based on data from the company's LYRICA Paediatric Epilepsy Programme, which were submitted in response to the US FDA's Written Request to evaluate the use of LYRICA as adjunctive therapy
for partial onset seizures in paediatric epilepsy patients.
"Removal without adjunctive therapy
is a guaranteed failure--about 100% of the time in my experience.
The approval was based on efficacy and safety data from a pivotal Phase III study, EXIST-3 (Examining everolimus In a Study of TSC), which found that when used as an adjunctive therapy
, Afinitor DISPERZ significantly reduced the frequency of treatment-resistant seizures associated with TSC compared to placebo.
A highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors, it is approved in countries around the world as an adjunctive therapy
for the treatment of POS with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
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.
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).
Lacosamide has already been approved as an adjunctive therapy
for partial onset seizures in adults with epilepsy in 36 countries.