PharmaNAC: Phase II trials for cystic fibrosis

Some may know that Stanford University researchers have been running Phase II clinical trials on PharmaNAC (an effervescent N-acetylcysteine tablet especially manufactured to maintain high potency) for cystic fibrosis. While a Phase I clinical trial is meant to assess just the safety of a drug, Phase II trials move on to look at the best dosage and how effective the drug is for a given condition.

In particular, a Phase IIA trial is generally designed to assess dosing requirements, while a Phase IIB trial seeks to measure efficacy (how well the drug works at various prescribed doses).

The Stanford research, supported by the Cystic Fibrosis Foundation and by federal funding, has already concluded the Phase IIA study. In the words of a study report, this phase of the research “demonstrates excellent safety and tolerability of 0.9g tid oral PharmaNAC in Cystic Fibrosis patients and suggests real anti-inflammatory effects.” (That’s 3 tablets a day of PharmaNAC, which is 900mg or .9g per tablet.)

A scientific presentation of the Phase IIA results was accessed by us at:

http://www.docstoc.com/docs/47758049/Cystic-fibrosis-(mucoviscidosis)

The Stanford team is now (Spring 2011) concluding the Phase IIB clinical trial. This is a multi-center trial, so there are groups of participants in a number of states:

http://clinicaltrials.gov/show/NCT00809094

You can read more about PharmaNAC, and purchase through NYBC’s nonprofit co-op at:

http://nybcsecure.org/product_info.php?products_id=258

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