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Drug Names(s): Qnexa, VI-0521, phentermine and topiramate, Qsiva (EU)
Description: Qnexa is a proprietary pharmaceutical treatment containing low doses of the active ingredients phentermine (15 mg) and topiramate (92 mg; with a controlled release formulation starting in Phase III), given once-daily in the morning.
Phentermine is an amphetamine that stimulates neurons to release or maintain high levels of catecholamine neurotransmitters, including norepinephrine, which suppress hunger signals and appetite. Dopamine may also play a role. Phentermine (the phen in the Fen-phen anorectic) is generically available as a appetite suppressant.
Topiramate (Topamax) is an anticonvulsant used to treat epilepsy in both children and adults. The mechanism of action of topiramate in obesity is unknown. It modulates effects at the gamma-aminobutyric acid (GABA-A) receptor and glutamate AMPA/kainate receptors, as well as producing state-dependent blockade of voltage-dependent Na+ or Ca2+ channels, but the relationship of these mechanisms to its weight-loss effect is unclear.
Deal Structure: Revenue splits for this drug are BioMedTracker estimates.
Vivus and ScinoPharm
In July 2012, ScinoPharm announced that its Tainan, Taiwan Facility will provide commercial manufacturing of topiramate active pharmaceutical ingredient (API) for VIVUS Qsymia.
VIVUS and Catalent
In July 2012, VIVUS entered into the Commercial Manufacturing and Packaging Agreementwith Catalent Pharma Solutions to which Catalent will manufacture and supply Qsymia (phentermine and topiramate extended-release) capsules CIV for the Company. Under the Agreement, the Company will purchase from Catalent the Product during the term of the Agreement for commercial use in the United States, Canada, the European Union and any other country that the Company and Catalent mutually agree to in writing. The Agreement commenced on the Effective Date and will continue for four years following the date of the first commercial sale of the Product by the Company to any third party, unless earlier...See full deal structure in Biomedtracker
Pink Sheet Qsymia Post-Marketing Requirements
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