Par says studies show PAR-101 appears to be effective in treating C.difficile-associated diarrhea

By E. Janene Geiss

Philadelphia, Dec. 19 - Par Pharmaceutical Cos. Inc. said Monday that studies showed PAR-101 was potentially efficacious in treating C. difficile-associated diarrhea (CDAD).

The positive results occurred in a phase 1b and phase 2a study of PAR-101 in patients with and without CDAD, according to a company news release.

The phase 1b study was a randomized, double-blind, multiple-dose, placebo-controlled study to evaluate pharmacokinetics, tolerance and safety of PAR- 101 in healthy volunteers.

Oral doses of PAR-101 150 mg, 300 mg and 450 mg were administered once-daily for 10 days. PAR-101 was well tolerated by all subjects at all doses with no adverse events considered to be drug related, officials said.

The absorption of PAR-101 was minimal with the majority of drug being eliminated in the feces.

In the proof-principle phase 2a study, PAR-101 was evaluated in 45 CDAD patients in order to select an appropriate dose for subsequent trials.

Subjects were randomized to receive either 50 mg, 100 mg, or 200 mg of treatment every 12 hours followed by clinical evaluation.

The clinical evaluation included relief of symptoms of CDAD, time to resolution of diarrhea and clinical recurrence. Plasma and fecal samples were collected to investigate the relationship among dose, concentration and excretion of PAR-101 in CDAD patients, officials said.

PAR-101 was well-tolerated by all subjects at all doses. Two patients in each of the two lower dose groups were transferred to conventional therapy for apparent treatment failure (41 of 45, or greater than 91% cured overall). None in the top dosing group were transferred.

Of the subjects that completed therapy, two of 41, or less than 5% of patients, had recurrence of symptoms within the six weeks of follow-up, one each in the low and high dose groups.

According to Centers for Disease Control and Prevention data published in Morbidity and Mortality Weekly Report, CDAD has been a cause of some mortality and significant morbidity in hospitalized patients. More recent and less commonly encountered strains of CDAD are exhibiting significantly higher rates of mortality and have been less responsive to current treatments, such as metronidazole.

"PAR-101 has the potential to address an emerging health problem for both patients in hospitals and patients living in health care related environments," John MacPhee, president of Par's branded products division, said in the release.

The studies were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, D.C.

Par, based in Spring Valley, N.Y., develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.

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