Trials & Filings

Cornerstone Launches Bethkis

Nebulized treatment for CF patients with Pseudomonas aeruginosa

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Cornerstone Therapeutics has launched of Bethkis (Tobramycin Inhalation Solution), a nebulized therapy indicated for the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.

Bethkis contains 300 mg of tobramycin, the most widely used aerosolized antibiotic in patients with CF. Bethkis’ concentrated formulation delivers the same amount of antibiotic as other available nebulized tobramycin products (300 mg) in 4 mLs, allowing nebulization in approximately 15 minutes via the PARI LC® PLUS.

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