The Launch of NOCTIVA™, the First and Only FDA-Approved Treatment for Nocturia Due to Nocturnal Polyuria

Truckee, CA (UroToday.com) Innovative product now available in the United States for a condition that interrupts sleep for over 40 million Americans - Avadel Pharmaceuticals plc announced the launch of NOCTIVA™ (desmopressin acetate), an emulsified microdose Nasal Spray. NOCTIVA is the first and only FDA-approved treatment proven to help adults with nocturia due to nocturnal polyuria, a condition which causes the kidneys to overproduce urine at night.¹ NOCTIVA safely and effectively treats a condition that causes more than 40 million Americans²to wake two or more times per night to use the bathroom, and prevents them from getting a good night’s sleep.

NOCTIVA’s innovative formulation works in the kidneys to lessen nighttime urine production. The nasal spray is a proprietary emulsified microdose of desmopressin combined with a permeation enhancer that increases the transport of NOCTIVA across the nasal mucosa. Delivered via a unique spray pattern, NOCTIVA’s breakthrough formulation substantially increases the bioavailability of the active drug, allowing for microdosing, rapid absorption and consistency from dose to dose.

NOCTIVA was studied in two clinical trials in patients who experienced on average two or more nighttime awakenings to urinate. Study patients received either 1.66 mcg or 0.83 mcg of NOCTIVA or a placebo for 12 weeks. Those using NOCTIVA were able to stay in bed an average of four hours or more before having to wake up to urinate (on average, an improvement greater than 50% relative to placebo vs 2.4-hour baseline). In fact, NOCTIVA responders using 1.66 mcg were able to stay in bed more than five hours before experiencing a nocturic episode.³

^{“Having a safe, effective medication to treat my patients suffering from nocturia due to nocturnal polyuria is a game changer for their quality of life,” said Dr. Steven A. Kaplan, Professor of Urology at the Icahn School of Medicine at Mount Sinai and Director of the Benign Urologic Diseases and Men’s Health Program at Mount Sinai Health System.}

“Nocturia is not only highly bothersome but has been underreported and understudied in terms of its long- and short-term health consequences, including increased risk of falls, fractures, and depression.” As part of the clinical development of NOCTIVA, a novel instrument was developed in collaboration with the FDA to evaluate the daytime and nighttime impacts of nocturia. Patients’ quality of life was assessed in one of the two clinical trials using the “Impact of Nighttime Urination (INTU)” Questionnaire, which evaluated 10 daytime and nighttime consequences of nocturia. Patients rated their bother in terms of concentration, tiredness, irritability and insufficient sleep using a 0-100 scale. The higher the score, the greater the impact. At the end of the clinical trial, patients taking 1.66 mcg of NOCTIVA demonstrated a 45% improvement in their quality of life score when compared to their baseline measure.

“We’re committed to getting patients the help they need to improve their quality of life,” Avadel CEO Michael Anderson said. “We’re working with specialists to provide a safe and effective treatment option to patients who suffer from nocturia due to nocturnal polyuria.”

Avadel is committed to making this innovative, patient-focused product widely accessible and affordable to those diagnosed with nocturia due to nocturnal polyuria. With the NOCTIVA Care+ program available at launch, patients will pay no more than $40 for the prescription.⁴

Please see Important Safety Information below and Full Prescribing Information at www.Noctiva.com.

References:

1. Weiss JP. Nocturia: focus on etiology and consequences. Rev Urol. 2012;14(3-4):48-55.
2. Bosch JLH, Weiss JP. The prevalence and causes of nocturia. J Urol. 2010;184(2):440-446.
3. Data on file.
4. Terms and conditions apply.

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