Ferring Pharmaceuticals has launched Noqdirna in the UK, offering the only licensed treatment for the symptomatic treatment of nocturia due to nocturnal polyuria in adults of all ages.
Nocturia is a condition characterised by the need to wake up once or more during the night to urinate, which impacts around 8.63 million people in the UK. Night-time overproduction of urine, or nocturnal polyuria, is thought to contribute in up to 76–88 percent of cases.
The condition can result in an increase in falls and fractures, due to the need for night-time bathroom trips or being tired during the day. Disrupted sleep from the condition can also impact physical, mental and emotional health in adults of all ages, leading to reduced daytime productivity, a decreased quality of life and an increased morbidity and mortality.
According to Ferring, the burden to the UK economy is estimated to be £1.35 billion a year through hospital costs of managing nocturia and its associated consequences, and £4.32 billion a year through work absenteeism and loss of productivity, further highlighting the need for an effective treatment option.
Noqdirna (oral lyophilisate desmopressin) is a once-daily pill designed to reduce the amount of urine the kidneys produce, with doses tailored specifically for men (50 µg) and women (25 µg). Approval of the drug is based on two Phase III studies (CS40 and CS41), which demonstrated that the treatment significantly reduced the average number of night-time urinations, compared with the placebo groups.
According to trial findings, Noqdirna nearly doubled the probability of patients achieving the primary endpoint of the studies - a reduction of night-time bladder voids by 33 percent, and also reduced nocturnal urine volume in men and women by more than 200 ml and increased time to first void in patients, enabling an average undisturbed sleep period of around 4.5 hours.
On the safety side, the drug was well tolerated with the most common adverse events being dry mouth, nausea, fatigue and headache which occurred at ≥5 percent.
"We know that nocturia can have a significant impact on quality of life, and also increased risk of falls and fractures," but can be very difficult to treat effectively, said Jonathan Rees, GP, Tyntesfield Medical Group, North Somerset, Founder of the Primary Care Urology Society. "Nocturnal polyuria often does not respond to lifestyle changes or medication currently available, so the addition of Noqdirna to our armoury is highly welcome, particularly as we can now use this in patients over 65 unlike existing desmopressin formulations."