Boehringer Ingelheim has started enrolling patients into Phase III trials that will investigate its blockbuster Spiriva in combination with a new compound, olodaterol, for the treatment of chronic obstructive pulmonary disease.
Spiriva (tiotropium), a long-acting muscarinic antagonist (LAMA) co-marketed with Pfizer, is the most prescribed COPD drug worldwide, while olodaterol is a novel once-daily long-acting beta-2 agonist (LABA) which Boehringer says has been developed as "an ideal partner" to its big-selling drug. The German company said it is putting the combo into late-stage studies on the back on promising olodaterol Phase III results, which will be published in the near future.
The first two studies will involve 2,500 patients at more than 500 trial sites. Both the fixed-dose combination and monotherapies will be administered once-daily, for 52 weeks, via Boehringer's Respimat Soft Mist inhaler.
Roland Buhl of the University of Mainz, the co-ordinating investigator for both trials, said “we hypothesise the combination…will provide superior efficacy compared with the once-daily mono compounds". He added that the addition of a LABA to Spiriva in one inhaler "could represent a significant advancement in COPD treatment".
Observers believe that LABA/LAMA combinations will be more effective than currently-available treatments in reducing the frequency of COPD exacerbations and will challenge the existing market leaders, namely Spiriva and GlaxoSmithKline’s Advair/Seretide (salmeterol/fluticasone).
Viramune XR gets EU OK
Boehringer has also announced that once-daily Viramune (nevirapine) prolonged-release has been approved by European regulators in combination with other antiretrovirals for the treatment of HIV-1 infection.
Viramune XR 400mg, which was approved by the US Food and Drug Administration earlier this year, was shown to be non-inferior to the older, twice-daily immediate-release 200mg tablet in trials.