NOCDURNA

What it is

NOCDURNA contains desmopressin acetate in sublingual wafer formulation, available in 25 microgram and 50 microgram strengths.

Approved indications

— Treatment of nocturia due to idiopathic nocturnal polyuria in adults who awaken two or more times each night to void and have not responded to lifestyle measures.

Key safety warnings

Hyponatraemia is a known risk with desmopressin, and desmopressin should not be used in patients with a history of unstable angina pectoris and/or known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics, or those with known hyponatraemia. Hyponatraemia associated with desmopressin use is generally due to fluid overload, and infants, elderly and patients with serum sodium levels in the lower range of normal may have an increased risk. Desmopressin acetate should be used with caution in patients with cardiovascular disease and the elderly, and considerations should be taken before use in patients with risk factors for or a history of thrombosis, atherosclerotic cardiovascular disease, atherosclerotic cerebrovascular disease or angioplasty, due to post-marketing reports of deep vein thrombosis, cerebrovascular accident, myocardial infarction and angina pectoris. The most frequently reported adverse reaction with desmopressin during post-marketing is hyponatraemia, which may cause headache, nausea, vomiting, water intoxication, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusion, decreased consciousness, generalised or local oedemas, and in severe cases brain oedema, hyponatraemic encephalopathy, convulsions, and coma. Rare cases of serious hypersensitivity reactions including anaphylactoid shock and reaction have been reported in association with desmopressin injections.

Contraindications

NOCDURNA is contraindicated in patients with hypersensitivity to desmopressin acetate or any of the excipients, habitual and psychogenic polydipsia, a history of unstable angina pectoris and/or known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics, known hyponatraemia, syndrome of inappropriate ADH secretion (SIADH), and von Willebrand's disease type IIB.

Regulatory history

NOCDURNA received TGA approval on 30 November 2016 for the treatment of nocturia due to idiopathic nocturnal polyuria in adults who awaken two or more times each night to void and have not responded to lifestyle measures. The 25 microgram and 50 microgram sublingual wafer formulations were first listed on the ARTG on 2 December 2016. The TGA found that all chemistry and quality aspects were adequately resolved, and although no new biopharmaceutic studies were provided for the new lower strengths, this was considered acceptable due to the identical formulation to the previously approved Minirin Melt.