PARIAerosol Research Institute (Starnberg, Germany) — a company celebrating its 100th year in aerosol science — recently reached another milestone with its eFlow nebulizer being used to deliver ALN-RSV01 from Alnylam Pharmaceutical (Cambridge, Massachetts) in a Phase I clinical trial for the treatment of respiratory syncytial virus infection (RSV).

eFlow, an electronic, portable nebulizer, is designed to enable efficient aerosolization of liquid medications through a vibrating, perforated membrane, PARI said. Compared to other nebulizer systems, eFlow can produce aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible amount of time, the company said. Combined with its silent mode of operation, palm-size, light weight, and battery use, eFlow is intended to reduce the burden of taking daily inhaled treatments.

“PARI’s mission is to use the needs of respiratory patients as the driving force and provide cost-effective, environmentally friendly products using innovative technology,” Kirsten Ayars, a spokeswoman for PARI, told Medical Device Daily. “The result is clinical advancements that help patients breathe easier.”

eFlow was used in its first clinical trials in 2000 and received FDA 510(k) market clearance in 2004. Last year eFlow’s first Phase III pivotal clinical trial was started with inhaled aztreonam lysinate for cystic fibrosis. In April the company was awarded a 2006 Medical Design Excellence Award for the device.

Ayars said eFlow is currently involved in several proof of concept studies. According to PARI, the goal for eFlow is to be able to deliver treatments in less than three minutes.

“We are pleased to offer PARI’s eFlow platform technology to administer Alnylam’s novel inhaled RNAi compound for RSV,” said Martin Knoch, PhD, managing director of PARI. “Our advanced nebulizer system appears to be ideally suited for delivering this delicate compound to infants’ lungs, which is the target site for RSV infection. eFlow’s efficiency and speed of delivery can often result in more effective treatments using a lower dose and volume of medication compared to traditional jet or ultrasonic nebulizers.”

PARI makes aerosol delivery systems such as eFlow for patients with asthma, chronic lung disease and cystic fibrosis and inhalable drug products in the area of chronic lung diseases. It reports several drug candidates in clinical development.

This year the privately-funded company is celebrating 100 years in the aerosol therapy sector. PARI initiated operations making therapeutic whirlpool baths, evolving into a company that focuses on the respiratory disease sector, Ayars said.

Founded in 1906 in Wuppertal, Germany, PARI produced its first plastic nebulizers in 1933. Until then, they were made of glass. The PARI “nozzle” was patented in 1953 and is still the key component in almost all of its nebulizers, the company said.

Earlier this year PARI was named the market dominator for high-end, differentiated nebulizers in the U.S. and Germany by Cambridge Consulting .

“This year is a time for celebration at PARI,” said Werner Gutmann, president of PARI Respiratory Equipment, noting the company’s celebration of 100 years in the industry as well as the Cambridge Consulting recognition. “We are thrilled to be recognized again as the market leader for advancing nebulizer science and providing quality products that enhance patients’ lives. Every day we are developing new and improved products for a wide variety of diseases and are pleased that the market prefers our nebulizer and compressor systems for respiratory therapies.”

PARI’s worldwide headquarters is in Starnberg, Germany, with a large presence in the U.S. and offices in Japan, the UK and China.

Because of eFlow’s advanced technology, Ayars said, it is licensed during drug development by pharmaceutical and biotech companies. Then, she said, eFlow is optimized to the drug candidate and the drug candidate is optimized to eFlow — creating a unique therapy.

“In order to create these unique therapies where drug and device are optimized to one another, the process starts sooner than when most devices are matched to drugs,” Ayars said.

PARI anticipates the FDA may require that the regulatory approval of the eFlow is linked to the approval of the drug to prevent overdosing of medications due to eFlow’s efficiency, Ayars said.

“There is a significant need for novel therapeutics to effectively treat patients with RSV infection, the leading cause of pediatric hospitalization in the U.S. today and a prevalent infection in immune-compromised adult populations,” said John DeVincenzo, MD, associate professor of pediatrics at the University of Tennessee Health Science Center (Knoxville).

According to PARI, RSV is a highly contagious virus that causes infections in the upper and lower respiratory tract associated with predictable seasonal outbreaks worldwide. It is the most common cause for infant hospitalization and a significant pathogen in the elderly. The RNAi therapeutic, ALN-RSV01, is a small interfering ribonucleic acid (siRNA) targeting the messenger RNA of the RSV N gene, thereby preventing viral replication, PARI said.

Other products the company makes include the PARI LC Plus, PARI Respiratory Equipment, the aerosol mask Bubbles the Fish II, PARI Proneb Ultra II and Max and the PARI Trek compact compressor which won a Frost & Sullivan innovation award last year.

“PARI is the most widely used nebulizer in ongoing clinical trials for new medications,” Ayars said.