A Centrally and Peripherally Acting Therapy

Our novel oral formulation of the small molecule drug nalbuphine is unlocking new market opportunities across chronic cough conditions, where there are few, if any, treatment options.

Haduvio has a dual mechanism of action, acting as both an antagonist (blocker) to the body’s mu opioid receptor and as an agonist (activator) to the kappa opioid receptor. These receptors are known to be critical mediators of cough.

The History
of Nalbuphine

In its injectable formulation, nalbuphine has a long history of efficacy and safety. It’s been approved and unscheduled for more than 20 years in the U.S. and EU for the acute relief of moderate to severe pain in the hospital setting.

Haduvio contains a unique formulation that extends the plasma half-life from ~2 hours for the injectable formulation to 9 hours with the extended release formulation, enabling twice-daily oral dosing and opening up its potential use in patients with chronic cough.

Haduvio has been administered to over 1,000 subjects* and has generated a consistent long-term safety profile up to one year on therapy.

*Includes patients in all indications’ studies and healthy volunteers.  

Haduvio acts both centrally and peripherally to reduce cough and is therefore hypothesized to block the cough signal, regardless of the initial cause.

A Multi-Targeted Approach for IPF Cough

The cause of chronic cough in IPF is unknown but is thought to be the result of a chemical or mechanical stimulation of the cough receptors, which send a message to the brain through the brain stem resulting in a message back to the lungs to cough. It is believed that IPF patients have an increased sensitivity to previously undetectable levels of cough stimuli (chemical or mechanical) resulting in chronic cough.   

Since mu and kappa receptors are found in the respiratory regions of the brain stem, lungs, and peripheral lung nerves, it is hypothesized that Haduvio can block the cough signal centrally and peripherally and result in cough reduction independent of the initial stimuli.

Due to its dual MOA, we believe Haduvio is well suited to address chronic cough across a variety of conditions.

For more information on our global clinical development programs, please visit our Pipeline page.