Our Product

What is Thiolanox®

Novoteris is focused on developing inhaled nitric oxide gas formulations to address some of the most serious and lethal respiratory tract infections. Our scientists have spent two decades studying and developing nitric oxide for the treatment of drug resistance infections in diseases such as tuberculosis, cystic fibrosis, bronchiectasis, and chronic sinus disease.

Thiolanox® is a pharmaceutical nitric oxide gaseous formulation supplied in high pressure cylinders at 5,000 ppm (0.5% v/v) blended with medical grade nitrogen. It is an investigational drug product that is being studies as an inhaled product for the treatment of airway colonization in patients with cystic fibrosis (CF). Thiolanox® is not approved for sale in the United States.

Inhaled Nitric Oxide Delivery Device
The Novoteris Inhaled Nitric Oxide Delivery Device (INODD) is a custom computerized trace-gas delivery device designed for the specific application of delivering a fixed concentration of 160-ppm nitric oxide to patients with cystic fibrosis and other respiratory infections as part of Novoteris’ anti-infective clinical trials. The INODD is capable of delivering this high concentration of nitric oxide without the need for adding oxygen.

About Nitric Oxide & Cystic Fibrosis

Thiolanox® is Novoteris’ inhaled antimicrobial gas and its active ingredient is a gaseous molecule called nitric oxide (NO). It is administered to spontaneously breathing patients for 30 minutes, 3-5 a day for multiple days and is delivered to patients at a dose of 160 ppm nitric oxide. The inhaled antimicrobial effect in patients with cystic fibrosis during pilot testing has resulted in improved lung function. Inhaled NO may potentially have other effects that might benefit the CF patient such as its potential anti-inflammatory, smooth-muscle relaxation and secretion thinning effects.

The pharmacology, toxicity, and safety data for inhaled NO in humans for other applications are well-established through both previously approved drugs by EMEA (Europe), TPD (Canada), FDA (USA) and many published studies. The synthetic NO gas produced for blending into Thiolanox® is an identical molecule to that naturally produced by the human body. There are no biochemical, pharmacokinetic or physical differences.

Thiolanox® was first shown to be safe and effective at reducing those bacteria frequently identified in patients with CF infections. This was demonstrated in both the laboratory and with pneumonia models in two other species prior to human use. A phase I clinical study in 10 healthy adult volunteers, under the auspices of government regulatory authorities, investigated the safety of delivery and the physiologic effects of inhaled 160 ppm Thiolanox® for 30 minutes, every four hours, five times a day for 5 consecutive days. The treatments were well tolerated without any significant adverse events.

In an open labeled non-randomized controlled study, 8 adult CF patients received 160ppm concentration of NO by inhalation for 30 min, three times daily, at a concentration of 160 ppm for two periods of 5 days each. The primary purpose of the study was to establish safety and this was confirmed without any finding of any serious drug-related adverse event. Secondary observations for the study included the effect on changes of bacterial and or fungal load after completion of the treatment from baseline and change in lung function (FEV1) from baseline. Specifically there was significant mean reduction of the colony forming units (cfu) of all bacteria (log10 cfu: pre: 7.4±2.7; post: 3.8±1.7; P=0.0008) and all fungi (log10 cfu: pre: 5.6±3.1; post: 2.6±2.4; P=0.0019). This also confirmed that NO treatment was effective against a wide variety of bacteria and fungi by several orders of magnitude including P. aeruginosa, S. maltophilia, S. aureus, including methicillin resistant S. aureus (MRSA), A. denitrificans, M. abscessus, C. albicans, A. fumigatus and A. flavus). Furthermore, it demonstrated complete eradication of extended broad spectrum β-lactamase (ESBL)-producing E. coli strain and two Aspergillus species.
Based on laboratory tests, in vivo models and healthy human data, the use of 160ppm inhaled NO is considered safe. Preliminary studies in adults with CF provides additional safety and efficacy evidence. Together, this provides strong rationale that Thiolanox® will be an effective therapy for individuals with CF and will result in increased lung function primarily by reduction in microbial loads.