PRTK - Paratek shares rise after FDA approves NUZYRA oral only dosing regimen

Paratek Pharmaceuticals (PRTK) announces that the U.S. FDA has approved the company’s supplemental New Drug Application ((sNDA)) for the oral-only dosing regimen of NUZYRA for the treatment of adults with community-acquired bacterial pneumonia ((CABP)).Shares up nearly 12% premarket.NUZYRA (omadacycline), the company’s lead commercial product, is an oral and intravenous antibiotic available in the U.S. for the treatment of adults with CABP and acute bacterial skin and skin structure infections.The approval of the oral-only dosing for the treatment of CABP expands the commercial opportunity for primary care promotion, which has a market opportunity estimate of $1.5B."The availability of an oral-only dosing regimen of NUZYRA in pneumonia helps address a significant gap for an effective, safe and well-tolerated oral antibiotic in the primary care setting," Christian Sandrock, Professor of Pulmonary Medicine & Director of Critical Care, UC Davis Health said.

For further details see:

Paratek shares rise after FDA approves NUZYRA oral only dosing regimen