(dailyRx News) Patients with moderate-to-severe COPD may have a new treatment option on the way. A new drug has been generating positive results in clinical trials and could improve lung function and ease symptoms.
Phase 2b clinical trials of Glycopyrrolate (GP MDI; PT001) have been successful so far. Using GP MDI twice a day via inhaler showed significant improvements in lung function when compared to a placebo. These positive results mean GP MDI could be begin Phase III trials in 2012.
Phase 2b clinical testing evaluates the drug's effectiveness at the prescribed dosage. The clinical trial tested the effective of four doses of GP MDI against four doses of a placebo and the U.S. Food and Drug Administration (FDA) approved COPD treatment, Atrovent.
GP MDI's results were similar to Atrovent. Additionally, GP MDI was considered safe and was well-tolerated among patients. A phase 3 trial would begin in 2012. Phase 3 trials test the drug on a much larger population and against the best current FDA-approved treatment.
GP MDI is an interesting candidate because it is quicker acting than long-acting beta-adrenoceptor agonist (LABA). LABA's, such as Advair, work over a long period of time, up to 12 hours. LABA's would be used as an alternative to multiple doses of an inhaled corticosteroid.
GP MDI is a Long-Acting Muscarinic Agonist (LAMA) which could be combined with a LABA to improve treatment.
According to Chuck Bramlage, chief executive officer for Pearl Therapeutics, GP MDI can help fill a gap in COPD treatment because there is no quicker alternative to the sustained treatment of a LAMA. Mr. Bramlage says,
“A significant part of the very large COPD market is driven by the use of BID (twice daily) LABAs and inhaled corticosteroids. However, a rapid-acting, BID LAMA to complement these options is not yet available.”
GP MDI will be used in combination with a LABA for a combined treatment called PT003. With successful results in a Phase 3 trial, PT003 can be marketed and sold but will continue to be evaluated for safety and effectiveness.
GP MDI could be a new treatment for moderate-to-severe COPD pending future clinical trial results. Considering how deadly COPD is, any new treatment is eagerly anticipated.