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News

PARI reusable nebulizer delivers cystic fibrosis treatments in Phase 3 clinical trial

PARI Respiratory Equipment : 11 March, 2008  (New Product)
PARI's LC STAR nebulizer and PRONEB Ultra II compressor are the exclusive delivery devices supporting Inspire Pharmaceuticals' second Phase 3 clinical trial for a potential new cystic fibrosis treatment.
PARI reusable nebulizers are considered the gold standard for clinical trials and are recommended in commercial sales including AstraZeneca's Pulmicort Respules, Sepracor's Xopenex and Brovana, Novartis' TOBI, Genentech's Pulmozyme, and DEY LP's Accuneb, Duoneb, and Perforomist.

'PARI has a strong track record of reliable and efficient, reproducible drug delivery, so it only makes sense that so many pharmaceutical companies look to PARI when developing new medications,' said Lisa Cambridge, director of clinical development at PARI Respiratory Equipment. 'Our LC STAR is a fine particle nebulizer that enables delivery of aerosols to the smaller airways of the lungs - beneficial for successful respiratory therapies.'

Known as TIGER-2, Inspire's second pivotal Phase 3 clinical trial with denufosol tetrasodium inhalation solution is beginning enrollment in the USA and Canada with patients age five years and older. The use of standard CF maintenance therapies is permitted during the trial.

The combination of PARI's LC STAR nebulizer and PRONEB Ultra II compressor provides for a quick treatment with high efficiency and minimal medication waste.

It is hoped that denufosol could be the first early intervention therapy available to CF patients that affects an early step in the progression of the disease. Denufosol for the treatment of cystic fibrosis has been granted Fast Track designation and orphan drug status in the USA by the FDA and orphan drug designation in Europe by the European Medicines Agency (EMEA).
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