DUBLIN, Ireland, Oct. 05, 2017 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), appear that abstracts for the analytic appraisal of Noctiva (previously “SER120”) for the assay of patients with nocturia due to nocturnal polyuria with accessory overactive float (OAB) will be presented in an articulate affiche presentation at Pelvic Floor Disorders (PFD) Week 2017, the American Urogynecologic Society’s anniversary accurate meeting.
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Douglas Van Drie, M.D., who specializes in urogynecology and reconstructive pelvic surgery, will present articulate affiche 127, “Evaluation of SER120 for the Assay of Patients with Nocturia due to Nocturnal Polyuria with Accessory Overactive Bladder,” authored by Van Drie, D., Lepor, H., Nitti, V., Cheng, M., Cheng, L., Fein, S., on Friday, Oct. 6 at 5:11 p.m. EST at the Rhode Island Convention Center in Providence, R.I.
“Nocturia is a medical action that affects about 40 actor bodies in the United States and represents an unmet medical allegation amid my urogynecological patients,” commented Van Drie. “The action after-effects in accepted caliginosity urination, which prevents patients from experiencing a normal, restful beddy-bye aeon and can advance to a cardinal of circuitous and cher co-morbidities and health-related consequences, such as caliginosity avalanche and fractures, broken daytime activity and productivity, and compromised affection of life.”
In an subset assay of Noctiva’s Phase III cardinal studies, 207 patients adversity from nocturia due to nocturnal polyuria with accessory overactive float were evaluated. Patients on Noctiva accustomed both a cogent abridgement in beggarly cardinal of nocturic episodes, a cogent advance to their all-embracing affection of activity and a abundant access in the time from bedtime to aboriginal nocturic abandoned compared to placebo.
Noctiva at doses of 1.66 and 0.83 mcg is able for the assay of patients with nocturia due to nocturnal polyuria with accessory OAB. Highlights of Dr. Van Drie’s presentation at Friday’s accident will include:
• The abridgement in beggarly nocturic episodes/night for the 1.66 mcg dosage was 2 times that of placebo (P=.0010) and about 2 times that of placebo for the 0.83 mcg dosage (P=.0076)
• The allotment of patients who accomplished ≥50% abridgement in beggarly nocturic nocturic episodes/night for the 1.66 mcg dosage was added than 3 times greater than placebo (P=.0007) and 0.83 mcg dosage was >2.5 times that of placebo (P=.0096)
• The accurate QoL Questionnaire (INTU) completed by the patients accustomed an about 6 times greater advance in the QoL for the 1.66 mcg dosage and about 5 times greater advance for the 0.83 mcg dosage compared to placebo. These after-effects accurate that abbreviating nocturic episodes activated with clinically allusive improvements in how these patients acquainted and functioned
• The breadth of time from bedtime to aboriginal nocturic abandoned was 2.4 times greater than placebo for the 1.66 mcg dosage (P=.0136) and 2.8 times abundant than placebo for the 0.83 mcg dosage (P=.0036)
About Noctiva™Noctiva is the aboriginal and alone conception of desmopressin acetate, a vasopressin analog, accustomed by the FDA for the assay of nocturia due to nocturnal polyuria in adults who activate at atomic two times per night to void. It is a proprietary low-dose conception of desmopressin acetate administered through a patent-protected preservative-free intranasal commitment system. Its nasal administering provides targeted absorption, a constant pharmacokinetic contour and accomplished bioavailability.* Noctiva is dosed as a distinct aerosol in one nostril 30 account afore bedtime, and is accustomed in two dosage forms of 0.83 mcg and 1.66 mcg. Noctiva is accepted to become accessible to patients in the additional division of 2018. (Full Prescribing Admonition available here).
Important Affirmation Admonition and Indication for Noctiva (desmopressin acetate)
*Data on file
WARNING: HYPONATREMIACall 1-877-622-2320 for a complete account of warnings.
• NOCTIVA can account hyponatremia, which is a action that occurs back you do not accept abundant sodium in your blood.
• Your doctor should adviser the sodium levels in your claret afore you alpha and while you are appliance NOCTIVA. Mild cases of hyponatremia may not accept any symptoms, but signs can accommodate nausea, vomiting, fatigue, dizziness, headache, confusion, beef cramps, activity restless, and in astringent cases, seizures and coma. It may be life-threatening if severe.
• Some bodies should not booty NOCTIVA because of a college accident of astringent hyponatremia. You should not booty NOCTIVA if you accept a lot of aqueous intake, accept an affliction that can account aqueous or electrolyte imbalances, or use bend diuretics (water pills like bumetanide or ethacrynic acid) or systemic or inhaled glucocorticoids (steroids like cortisone or prednisone).
• You may allegation to briefly or assuredly stop demography NOCTIVA if you get hyponatremia.
What is NOCTIVA acclimated for?NOCTIVA is a decree anesthetic nasal (nose) aerosol acclimated in adults who deathwatch up two or added times during the night to defecate due to a action alleged nocturnal polyuria. Nocturnal polyuria is a action area your anatomy makes too abundant urine at night. There are added altitude that could account you to deathwatch up during the night to urinate. NOCTIVA is alone accustomed for the assay of nocturnal polyuria. Your doctor should accept you admeasurement your urine and the times that you defecate for 24 hours to actuate if you accept nocturnal polyuria if you accept not already done this.
NOCTIVA is not advised for use in children. It has not been advised in adults beneath than 50 years old, so it is alien whether NOCTIVA is safe or able in bodies beneath this age.
Who should not booty NOCTIVA?You should not booty NOCTIVA if you:
• have or accept had low alkali levels in your blood
• are agog abundant of the time and alcohol ample amounts of fluids (polydipsia)
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• wet the bed while sleeping at night
• are demography a blazon of water-pill alleged a loop-diuretic
• are demography a glucocorticoid (steroid) medicine, including an inhaled glucocorticoid (steroid) medicine
• have abstinent to astringent branch problems
• have or may accept a action alleged affection of inappropriate antidiuretic hormone (SIADH) secretion
• have an affliction that can account you to accept low levels of aqueous or electrolytes in your blood, such as vomiting, diarrhea, an infection, or a branch botheration that causes you to lose too abundant salt
• have affection from a affection botheration alleged congestive affection failure
• have aerial claret burden that is not controlled
Ask your doctor if you are not abiding you accept any of these altitude or booty any of the types of medicines listed.
What is the best important admonition you should apperceive about NOCTIVA?
NOCTIVA can account hyponatremia (low levels of sodium in the blood). Astringent cases can advance to seizures, coma, or death. It can account aqueous assimilation (water weight gain), which can be a accurate botheration for bodies with congestive affection abortion or amoral aerial claret pressure.
Call your doctor if you accept any of the afterward affection of low alkali levels in your blood:
• headache
• nausea or vomiting
• drowsiness
• dizziness
• muscle cramps
• feeling restless
• fatigue
• change in your brainy condition, such as confusion, or decreased acquaintance or alertness
Low alkali levels in the claret appear added generally in bodies advised with NOCTIVA who are 65 years old or earlier than in bodies advised with NOCTIVA who are adolescent than 65 years old. Your doctor should analysis the alkali levels in your claret afore you alpha or re-start demography NOCTIVA, during assay with NOCTIVA, and afore accretion your dose.
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Ask your doctor if you should briefly abandon NOCTIVA if you accept allergies or a algid that makes your adenoids aqueous or blimp up, as accepting such affection could affect how your anatomy absorbs the anesthetic in NOCTIVA.
What should you acquaint your bloom affliction provider?
Before appliance NOCTIVA, acquaint your bloom affliction provider about all of your medical conditions, including if you:
• have vomiting, diarrhea, fever, or infection
• have branch or affection problems
• have diabetes mellitus
• have had a arch injury
• have a affection botheration alleged congestive affection failure
• have a history of not actuality able to abandoned your float all of the way (urinary retention)
• have any adenoids problems, such as blockage, airless nose, aqueous nose, or drainage
• are abundant or plan to become pregnant. It is not accepted if NOCTIVA can abuse your approaching baby.
• Are breastfeeding or plan to breastfeed. Desmopressin, and additive in NOCTIVA, passes into breast milk. Allocution to your doctor about the best way to augment your babyish if you use NOCTIVA.
Tell your doctor about all the medicines you take, including decree and over-the-counter medicines, vitamins, and herbal supplements. Appliance NOCTIVA with assertive added medicines may account austere ancillary effects. Do not alpha demography any new medicines until you allocution to your doctor.
Especially acquaint your doctor if you booty a:
• water bolus (diuretic)
• glucocorticoid (steroid) medicine, including an inhaled glucocorticoid (steroid) medicine
• medicine acclimated to amusement abasement alleged a tricyclic antidepressant or careful serotonin reuptake inhibitor (SSRI)
• medicine acclimated to amusement affection disorders, such as schizophrenia or bipolar ataxia alleged chlorpromazine
• medicine acclimated to amusement seizures, assumption pain, or bipolar ataxia alleged carbamazepine
• non-steroidal anti-inflammatory anesthetic (NSAID)
• medicine that you use in your nose
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There accept not been any studies done to see if added medicines ability collaborate with NOCTIVA. Ask your doctor or pharmacist if you are not abiding if your anesthetic is one of the types listed above, or if you are borderline whether any of the medicines you already booty ability put you at added accident of ancillary effects.
How should you booty NOCTIVA?You should use NOCTIVA absolutely as instructed by your bloom affliction professional. Your doctor has assigned the backbone that is best for you, and you should not use added than 1 aerosol of the assigned dosage at a time, alike if you absent a above-mentioned dose.
What are the ancillary furnishings of NOCTIVA?NOCTIVA may account austere ancillary effects, including hyponatremia, which may advance to austere or life-threatening conditons, including seizure, coma, agitation breathing, or afterlife if not advised early. NOCTIVA may additionally account your anatomy to authority too abundant baptize (fluid retention).The best accepted ancillary furnishings of NOCTIVA include:
• nose discomfort
• pain or abscess (inflammation) in your adenoids or throat
• stuffy nose
• sneezing
• high claret pressure
• back pain
• nosebleed
• inflammation of the lining of the bronchial tubes that backpack air to and from your lungs that causes a ahem (bronchitis)
• dizziness
These are not all of the accessible ancillary furnishings of NOCTIVA. You are encouraged to alarm your doctor for medical admonition about ancillary effects, and you can additionally address them to the FDA.
To address SUSPECTED SIDE EFFECTS, acquaintance Avadel Specialty Pharmaceuticals, LLC, at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please be acquainted that this is not a complete advertisement of all affirmation admonition associated with NOCTIVA. For added information, alarm 1-877-622-2320.
About Avadel Pharmaceuticals plc:Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a specialty biologic aggregation that seeks to commercialize differentiated biologic articles that are safe, able and accessible to booty through conception development, by utilizing its proprietary biologic commitment technology and in-licensing / accepting new products; ultimately, allowance patients attach to their assigned medical assay and see bigger results. The Aggregation is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France. For added information, amuse appointment www.avadel.com.
Safe Harbor
This columnist absolution may accommodate advanced statements aural the acceptation of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “will,” “may,” “believe,” “expect,” “anticipate,” “estimate,” “project” and agnate expressions, and the negatives thereof, analyze advanced statements, anniversary of which speaks alone as of the date the account is made. Although we accept that our advanced statements are based on reasonable assumptions aural the bound of our ability of our business and operations, our business is accountable to cogent risks and as a aftereffect there can be no affirmation that absolute after-effects of our research, development and commercialization activities and our after-effects of operations will not alter materially from the after-effects advised in such advanced statements. These risks include: (i) risks apropos to our authorization acceding with Serenity Pharmaceuticals, LLC including that our centralized analyses may enlarge the bazaar befalling in the United States and Canada for the biologic desmopressin acetate (the “Drug”) or we may not finer accomplishment such bazaar opportunity, that cogent affirmation or biologic alternation problems could appear with account to the Drug, that we may not auspiciously access acquaintance of nocturia and the abeyant allowances of the Drug, and that the allegation for administration to focus absorption on the development and commercialization of the Biologic could account our advancing business operations to suffer; and (ii) the added risks, uncertainties and contingencies declared in the Company's filings with the U.S. Securities and Exchange Commission, including our anniversary address on Form 10-K for the year concluded December 31, 2016, in accurate beneath the captions “Forward-Looking Statements” and “Risk Factors,” including afterwards limitation: our assurance on a baby cardinal of articles and barter for the majority of our revenues; the achievability that our Bloxiverz®,Vazculep® and Akovaz® products, which are not apparent protected, could face abundant antagonism consistent in a accident of bazaar allotment or banishment us to abate the prices we allegation for those products; the achievability that we could abort to auspiciously complete the analysis and development for activity articles we are evaluating for abeyant appliance to the FDA pursuant to our "unapproved-to-approved" strategy, or that competitors could complete the development of such articles and administer for FDA approval of such articles afore us; the achievability that our articles may not ability the bartering bazaar or accretion bazaar acceptance; our allegation to advance abundant sums in analysis and development in adjustment to abide competitive; our assurance on assertive distinct providers for development of several of our biologic commitment platforms and products; our assurance on a bound cardinal of suppliers to accomplish our articles and to bear assertive raw abstracts acclimated in our products; the achievability that our competitors may advance and bazaar technologies or articles that are added able or safer than ours, or access authoritative approval and bazaar such technologies or articles afore we do; the challenges in attention the bookish acreage basal our biologic commitment platforms and added products; and our assurance on key cadre to assassinate our business plan. Except as may be appropriate by law, we abandon any obligation to about amend any advanced statements to reflect contest afterwards the date of this columnist release.
Contacts
Media:Alli WentlingFleishmanHillardPhone: (314) 986-6295Email: alli.wentling@fleishman.com
Investors:Mike KananAvadelPhone: (636) 449-1844Email: mkanan@avadel.com
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Lauren StivalAvadelPhone: (636) 449-5866Email: lstival@avadel.com
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