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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PharmaNAC (effervescent n-acteylcysteine) and MAC-Pack (K-Pax alternative)

A few words about PharmaNAC, an effervescent NAC (n-acetylcysteine) that the New York Buyers’ Club has been supplying in the past year. This form of NAC has proven especially useful to people with respiratory conditions like chronic bronchitis. And we were interested to read recently of a person with cystic fibrosis reporting on her use of PharmaNAC.

NAC in various forms has been researched and used more widely in Europe than in the US, although some influential work on this supplement for people with HIV was conducted at Stanford back in the 1990s, and helped lead, for example, to the inclusion of NAC in K-Pax, a multivitamin antioxidant combination that showed significant enough benefit to be added to state government-financed formularies for people with HIV.

NYBC originally imported a German effervescent NAC called ACC Akut (Hexal), but we were delighted when a North American supplier began to offer the very similar PharmaNAC, which we have stocked for the past year. (PharmaNAC is actually a higher dose of NAC per tab–900mg–than ACC Akut’s 600mg, though we have been able to keep the price about the same due to lower shipping costs.)

NYBC’s mission as a nonprofit buyers’ co-op also motivated us to devise a low-cost alternative to K-Pax for those who don’t have access to subsidized versions of this product. The NYBC MAC-Pack provides a close equivalent to K-Pax, but the cost has been brought down to less than half that of K-Pax.

Note: it’s also possible to order non-effervescent NAC and ThiolNAC separately:

NAC 500mg/90 tabs

ThiolNAC (500mg NAC and 200mg alpha lipoic acid/90 tabs)

PharmaNAC at the New York Buyers’ Club

The New York Buyers’ Club stocks PharmaNAC, an effervescent form of N-acetylcysteine (NAC) produced in North America by BioAdvantex, which is also the supplier of our high-quality whey protein powder, Ultimate Balance.

PharmaNAC is a high-quality preparation of NAC, a supplement that has been studied extensively for immune system support, and for support of respiratory tract function. Currently forms of NAC (including effervescent forms) are more widely used in Europe than in North America, but this may change as its benefits are more generally recognized and studies continue.

A bit of anecdotal evidence: we have noticed some positive reviews of PharmaNAC in online forums dealing with cystic fibrosis.