PRILIGY

What it is

PRILIGY is available as 30 mg tablets, each containing 30 mg of dapoxetine base as hydrochloride. PRILIGY 30 mg consists of light grey film-coated tablets debossed with "30" inside a triangle on one side. Dapoxetine inhibits the serotonin transporter, and its mechanism of action in premature ejaculation is presumed to be linked to inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre- and post-synaptic receptors.

Approved indications

— Treatment of premature ejaculation in men 18 to 64 years of age who have all of the following: an intravaginal ejaculatory latency time of less than two minutes; persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; marked personal distress or interpersonal difficulty as a consequence of PE; and poor control over ejaculation.

Dosing overview

The recommended dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Patients must not take more than one tablet once every 24 hours due to increased risk of side effects and lack of additional benefit, and the maximum recommended dosing frequency is once every 24 hours. PRILIGY is not intended for continuous daily use and should be taken only when sexual activity is anticipated. A careful appraisal of individual benefit-risk should be performed by the physician after the first four weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment is appropriate.

Key safety warnings

Patients on PRILIGY need to be made aware that they could experience syncope at any time with or without prodromal symptoms during their treatment, and syncope characterised as loss of consciousness has been reported in clinical trials and is considered medicinal product-related. Prodromal symptoms such as nausea, dizziness or light-headedness often preceded the syncope, and patients should be counselled about the importance of maintaining adequate hydration and about how to recognise and act upon prodromal signs and symptoms to decrease the likelihood of serious injury associated with falls due to loss of consciousness. In Phase 3 studies involving 6081 randomised subjects, the frequency of syncope characterised as a loss of consciousness was 0.06% for PRILIGY 30 mg and 0.05% for placebo. Patients should be advised not to use PRILIGY in combination with alcohol, as combining alcohol with PRILIGY may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury. PRILIGY has minor or moderate influence on the ability to drive and use machines, as dizziness, disturbance in attention, syncope, blurred vision and somnolence have been reported in subjects receiving PRILIGY in clinical trials, and patients should be warned to avoid situations where injury could result, including driving or operating hazardous machinery. PRILIGY should be used with caution in patients with raised intraocular pressure or those at risk of angle closure glaucoma.

Contraindications

PRILIGY is contraindicated in patients with known hypersensitivity to dapoxetine hydrochloride or to any of the excipients. PRILIGY is contraindicated in patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities such as AV block or sick sinus syndrome, significant ischaemic heart disease or significant valvular disease, and history of syncope. PRILIGY is contraindicated in patients with a history of mania or severe depression. PRILIGY is contraindicated for concomitant treatment with monoamine oxidase inhibitors, or within 14 days of discontinuing treatment with an MAOI, and an MAOI should not be administered within 7 days after PRILIGY has been discontinued. PRILIGY is contraindicated for concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine, and thioridazine should not be administered within 7 days after PRILIGY has been discontinued. PRILIGY is contraindicated for concomitant treatment with serotonin reuptake inhibitors or other medicinal and herbal products with serotonergic effects, or within 14 days of discontinuing treatment with these products. PRILIGY is contraindicated for concomitant treatment with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, and atazanavir. PRILIGY is contraindicated in patients with moderate and severe hepatic impairment.

Regulatory history

PRILIGY received approval for registration on 2010-08-27. PRILIGY dapoxetine 30 mg film-coated tablet was first listed on the ARTG on 2010-09-02. The 30 mg tablet strength of PRILIGY was approved for registration, while the 60 mg tablet strength was withdrawn from the submission. The TGA's evaluation found the product adequately formulated with satisfactory chemistry and quality control, and bioavailability was deemed acceptable.