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

PharmaNAC at NYBC

PharmaNAC, an effervescent tablet formulation of NAC (N-acetylcysteine), has been available from the New York Buyers Club for several years. We are pleased to offer this formulation, both because it’s a high quality preparation with careful manufacturing controls and protective packaging, and because ongoing research on NAC has continued to point to its usefulness in many fields, from respiratory and immune system support to serving as an antidote to acetaminophen (common tradename: Tylenol) overdose.

Here are some product details from the manufacturer:

N-acetylcysteine or “NAC” for short, is a derivative of the amino acid L-cysteine, which is an essential precursor used by the body to produce glutathione. Glutathione is an important and powerful antioxidant produced by the body to help protect against free radical damage, and is a critical factor in supporting a healthy immune system.

PharmaNAC:
• Certified European Good Manufacturing Process (GMP) grade NAC.
• Effective way to help boost glutathione levels.
• Effervescent, quick-dissolving tablets allow NAC to enter cells readily, ensuring rapid absorption.
• Quality controlled according to pharmaceutical guidelines.
• Compliant to the standards of European Pharmacopoeia and United States Pharmacopoeia.
• Individually wrapped tablets in a 4-layer (paper/plastic/foil plastic) air-tight material to prevent moisture and air from degrading the NAC (a major problem with most other over the counter NAC).

For information on purchasing, see the NYBC entry at

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

PharmaNAC study: cystic fibrosis

A phase 2B clinical study of individuals over the age of 7 is enrolling among people living with cystic fibrosis. The study is looking at the efficacy of PharmaNAC, the effervescent form of NAC that is used by many of us living with chronic infections or conditions. It is enrolling people at various sites in the United States.

NAC is one of the rate-limiting steps in the production of the tripeptide, glutathione. Glutathione is an antioxidant that is critical for the proper functioning of many cells in the body and has particular importance for the liver, lungs, heart, muscles and nervous system. An abstract from the results of a European study of NAC in cystic fibrosis is found below.

    For more information on the study, click on this sentence.

Further information from the Cystic Fibrosis Foundation is found here (although, as they note digestibility may present a problem for some antioxidants, one wonders if agents like glutamine and acidophilus might not also improve outcomes of the use of other agents? This is just a speculation–we need to investigate this further and welcome any input or thoughts.)

Dauletbaev N, Fischer P, Aulbach B, Gross J, Kusche W, Thyroff-Friesinger U, Wagner TO, Bargon J. A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis. Eur J Med Res. 2009 Aug 12;14(8):352-358.
University Hospital, Frankfurt/Main, Germany.

OBJECTIVE: We conducted a single-centre, randomised, double-blinded, placebo-controlled phase II clinical study to test safety and efficacy of a 12-week therapy with low-dose (700 mg/daily) or high-dose (2800 mg/daily) of NAC. METHODS: Twenty-one patients (DeltaF508 homo/heterozygous, FEV1>40% pred.) were included in the study. After a 3-weeks placebo run-in phase, 11 patients received low-dose NAC, and 10 patients received high-dose NAC. Outcomes included safety and clinical parameters, inflammatory (total leukocyte numbers, cell differentials, TNF-alpha, IL-8) measures in induced sputum, and concentrations of extracellular glutathione in induced sputum and blood. RESULTS: High-dose NAC was a well-tolerated and safe medication. High-dose NAC did not alter clinical or inflammatory parameters. However, extracellular glutathione in induced sputum tended to increase on high-dose NAC. CONCLUSIONS: High-dose NAC is a well-tolerated and safe medication for a prolonged therapy of patients with CF with a potential to increase extracellular glutathione in CF airways.

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See the NYBC entry on PharmaNAC for information on purchasing PharmaNAC from the nonprofit purchasing co-op.

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)