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Adzenys XR-ODT Whole Prescription (TRx) Unit Development Pushed by a Mixture of Continued Gross sales Pressure Execution, Leveraging of the Aytu RxConnect Affected person Assist Program, and a Constructive Response to the Adderall® XR Provide Disruption
Adzenys XR-ODT is the Solely FDA-Authorised, Prolonged-Launch, Orally Disintegrating Pill Formulation of Amphetamine
Adzenys XR-ODT Continues to be Out there as an FDA-Authorised Bioequivalent Various to Adderall XR
ENGLEWOOD, CO / ACCESSWIRE / November 30, 2022 / Aytu BioPharma, Inc. (the Firm or “Aytu”) (NASDAQ: AYTU), a business stage pharmaceutical and shopper well being firm offering pediatric-focused prescribed drugs and cost-effective shopper well being options, right this moment introduced the very best weekly prescription complete for Adzenys XR-ODTÂ® (amphetamine) extended-release orally disintegrating tablets, CII, for the reason that inception of the Aytu RxConnect affected person assist program.
For the week ending November 18, 2022, a document 5,186 complete prescriptions have been crammed for Adzenys XR-ODT. Adzenys XR-ODT prescriptions are up 9.9% over the previous thirteen-week interval.
Adzenys XR-ODT has a twelve-hour length of motion, has been FDA-approved as bioequivalent to AdderallÂ® XR, and is on the market in six equal strengths as follows:
Josh Disbrow, Chief Government Officer of Aytu, stated, “We’re happy with the persevering with development of Adzenys XR-ODT, pushed partially via our gross sales staff’s execution within the discipline and our messaging to clinicians. Particularly, we proceed to tell our clinician companions that Adzenys XR-ODT, an FDA-approved bioequivalent various to Adderall XR, continues to be accessible for his or her sufferers. Given the persevering with provide disruptions many sufferers and clinicians have confronted this fall and should face into 2023, we’re happy to supply Adzenys XR-ODT as a possible various to Adderall XR. Entry to Adzenys XR-ODT is straightforward, handy, and value efficient for sufferers through the Aytu RxConnect program and our community of roughly 1,000 pharmacies nationwide.”
Adzenys XR-ODT stays accessible in mild of quite a few reported provide disruptions affecting generic Adderall XR (blended salts amphetamine) extended-release capsule, CII for the therapy of consideration deficit hyperactivity dysfunction (ADHD). Aytu BioPharma has maintained constant Adzenys XR-ODT manufacturing ranges at its Grand Prairie, Texas manufacturing facility to make sure ongoing provide of Adzenys XR-ODT, which has skilled no provide disruptions so far.
About Adzenys XR-ODT
Adzenys XR-ODT is on the market by prescription solely, is bioequivalent to Adderall XR, and is the one FDA-approved, extended-release, orally disintegrating pill formulation of amphetamine. Adzenys XR-ODT is indicated for the therapy of ADHD in sufferers six years and older. Adzenys XR-ODT is on the market at retail pharmacies and thru the Aytu RxConnect affected person assist program.
Go to www.AdzenysXRODT.com for extra info together with dose choice and titration schedule.
To find an Adzenys XR-ODT pharmacy in a affected person’s space please go to www.AytuRxConnect.com.
What’s Adzenys XR-ODT?
Adzenys XR-ODT is a central nervous system stimulant prescription drugs used for the therapy of ADHD in sufferers 6 years and older.
Vital Security Info
- Recognized hypersensitivity to amphetamine or different components in Adzenys XR-ODT. Angioedema and anaphylactic reactions have been reported in sufferers handled with different amphetamine merchandise.
- Taking a monoamine oxidase inhibitor (MAOI), or have taken an MAOI throughout the previous 14 days. Hypertensive disaster can happen.
Vital Security Info
Adzenys XR-ODT is a federally managed substance (CII) as a result of it may be abused or result in dependence. Preserve Adzenys XR-ODT in a protected place to forestall misuse and abuse. Promoting or giving freely Adzenys XR-ODT could hurt others and is in opposition to the legislation.
Inform your physician should you or your baby has ever abused or been depending on alcohol, prescription medicines, or avenue medication.
Who mustn’t take Adzenys XR-ODT?
Don’t take Adzenys XR-ODT should you or your baby is:
- allergic to amphetamine or any components in Adzenys XR-ODT.
- taking or has taken an anti-depression drugs referred to as monoamine oxidase inhibitor (MAOI) throughout the previous 14 days.
Adzenys XR-ODT is a stimulant drugs. Inform your physician about well being situations, together with if:
- you or your baby has any coronary heart issues, coronary heart defects, hypertension, or a household historical past of those issues. That is necessary as a result of sudden loss of life has occurred in folks with coronary heart issues or defects, and sudden loss of life, stroke and coronary heart assault have occurred in adults. Your physician ought to examine for coronary heart issues previous to prescribing Adzenys XR-ODT and can examine you or your kid’s blood stress and coronary heart price throughout therapy. Name the physician straight away should you or your baby has any indicators of coronary heart issues akin to chest ache, shortness of breath, or fainting whereas taking Adzenys XR-ODT.
- you or your baby has psychological issues, or a household historical past of suicide, bipolar sickness, or despair. That is necessary as a result of the next might happen: new or worse conduct and thought issues, new or worse bipolar sickness, new psychotic signs (listening to voices, believing issues that aren’t true, are suspicious) or new manic signs. Name the physician straight away if there are any new or worsening psychological signs throughout therapy.
- you or your baby has circulation issues in fingers and toes (peripheral vasculopathy, together with Raynaud’s phenomenon). Fingers or toes could really feel numb, cool, painful, delicate to temperature and/or change colour from pale, to blue, to pink. Name the physician straight away if any indicators of unexplained wounds seem on fingers or toes whereas taking Adzenys XR-ODT.
- your baby is having slowing of development (top and weight). Your baby ought to have his or her top and weight checked usually whereas taking Adzenys XR-ODT. The physician could cease therapy if an issue is discovered throughout these check-ups.
- you or your baby has kidney issues. Your physician could decrease the dose.
- you or your baby is or plans to turn out to be pregnant.
- you or your baby is breastfeeding or plans to breastfeed. You shouldn’t breastfeed whereas taking Adzenys XR-ODT.
- you or your baby takes any medicines, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. Adzenys XR-ODT and a few medicines could work together with one another and trigger critical unintended effects.
- Don’t begin any new drugs whereas taking Adzenys XR-ODT with out speaking to your physician first.
What ought to I keep away from whereas taking Adzenys XR-ODT?
Frequent unintended effects of Adzenys XR-ODT embrace:
- Decreased urge for food and issues sleeping.
- Kids 6 – 12 Years additionally embrace: Abdomen ache, excessive temper change, vomiting, nervousness, nausea, and fever.
- Kids 13 – 17 Years additionally embrace: Abdomen ache and weight reduction.
- Adults additionally embrace: Dry mouth, headache, weight reduction, nausea, anxiousness, restlessness, dizziness, quick coronary heart beat, diarrhea, weak point, and urinary tract infections.
These are usually not all of the attainable unintended effects of Adzenys XR-ODT. Name your physician for medical recommendation about unintended effects.
For added security info, click on right here for Prescribing Info and Remedy Information and focus on together with your physician.
To report suspected opposed reactions, contact Aytu BioPharma at 855-AYTU-BIO (855-298-8246). You’re inspired to report destructive unintended effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch, or name 1-800-FDA-1088.
In line with the Facilities for Illness Management and Prevention, ADHD is among the most typical childhood problems and might proceed via adolescence and maturity. In truth, ADHD is estimated to have an effect on 5 % of kids and a couple of.5 % of adults within the U.S. Signs embrace inattentiveness, hyperactivity and impulsiveness. These patterns of conduct are seen in lots of settings (faculty, house, work) and might impression efficiency and relationships.
Stimulant medicines akin to amphetamine and methylphenidate are the usual of take care of treating ADHD, and extended-release (XR) formulations of those medicines permit for once-daily dosing. Many of the current therapy formulations are tablets or capsules, which must be swallowed intact or in some instances sprinkled on sure meals or fluids and ingested instantly. Orally disintegrating tablets differ from conventional tablets and capsules in that they’re designed to disintegrate within the mouth, moderately than being swallowed entire.
About Aytu BioPharma, Inc.
Aytu BioPharma is a pharmaceutical firm commercializing a portfolio of business prescription therapeutics and shopper well being merchandise. The Firm’s prescription merchandise embrace Adzenys XR-ODTÂ® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Info, together with Boxed WARNING) and Cotempla XR-ODTÂ® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Info, together with Boxed WARNING) for the therapy of consideration deficit hyperactivity dysfunction (ADHD), in addition to KarbinalÂ® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to deal with quite a few allergic situations, and Poly-Vi-FlorÂ® and Tri-Vi-FlorÂ®, two complementary fluoride-based prescription vitamin product traces accessible in varied formulations for infants and youngsters with fluoride deficiency. Aytu’s shopper well being section markets a spread of over-the-counter medicines, private care merchandise, and dietary dietary supplements addressing a spread of frequent situations together with diabetes, allergy, hair regrowth, and gastrointestinal situations. To be taught extra, please go to aytubio.com.
This press launch consists of forward-looking statements throughout the that means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Alternate Act of 1934, or the Alternate Act. All statements aside from statements of historic details contained on this press launch, are forward-looking statements. Ahead-looking statements are usually written sooner or later tense and/or are preceded by phrases akin to ”could,” ”will,” ”ought to,” ”forecast,” ”might,” ”count on,” ”counsel,” ”consider,” ”estimate,” ”proceed,” ”anticipate,” ”intend,” ”plan,” or related phrases, or the negatives of such phrases or different variations on such phrases or comparable terminology. All statements aside from statements of historic details contained on this press launch, are forward-looking statements, together with however not restricted to any statements concerning the monetary outcomes and statements introduced on this press launch and through the enterprise replace name following its launch. These statements are simply predictions and are topic to dangers and uncertainties that might trigger the precise occasions or outcomes to vary materially. These dangers and uncertainties embrace, amongst others: the supply of Adzenys XR-ODT and the long run gross sales of Adzenys XR-ODT. We additionally refer you to (i) the dangers described in ”Danger Components” in Aytu’s Annual Report on Type 10-Okay, in Quarterly Studies filed on Type 10-Q, and within the different experiences and paperwork it information with the Securities and Alternate Fee.
Contacts for Traders:
Mark Oki, Chief Monetary Officer
Aytu BioPharma, Inc.
Robert Blum or Roger Weiss
SOURCE: Aytu BioPharma, Inc.
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