Aytu BioPharma Appoints Dr. Gerwin Westfield as Senior Vice President of Scientific Affairs to Support Commercialization of EXXUA(TM)
Aytu BioPharma (Nasdaq:AYTU) has appointed Dr. Gerwin Westfield as Senior Vice President of Scientific Affairs, effective June 30, 2025. Dr. Westfield, a former Aytu executive and Nobel Prize contributor, will oversee medical and scientific affairs strategies, focusing on the commercial launch of EXXUA™.
EXXUA, a novel FDA-approved treatment for major depressive disorder (MDD), is set to launch in Q4 2025. As the first-in-class selective serotonin 5HT1a receptor agonist, EXXUA will compete in the $22 billion U.S. prescription MDD market. Notably, it's the only serotonin-targeting antidepressant without sexual dysfunction warnings, and has been tested in over 5,000 patients.
Aytu BioPharma (Nasdaq:AYTU) ha nominato Dr. Gerwin Westfield come Senior Vice President degli Affari Scientifici, con effetto dal 30 giugno 2025. Il Dr. Westfield, ex dirigente di Aytu e collaboratore al premio Nobel, supervisionerà le strategie mediche e scientifiche, concentrandosi sul lancio commerciale di EXXUA™.
EXXUA, un nuovo trattamento approvato dalla FDA per il disturbo depressivo maggiore (MDD), sarà lanciato nel quarto trimestre del 2025. Essendo il primo agonista selettivo del recettore serotoninergico 5HT1a della sua categoria, EXXUA entrerà in competizione nel mercato statunitense delle prescrizioni per MDD da 22 miliardi di dollari. È importante sottolineare che è l’unico antidepressivo che agisce sulla serotonina senza avvertenze relative alla disfunzione sessuale, ed è stato testato su oltre 5.000 pazienti.
Aytu BioPharma (Nasdaq:AYTU) ha nombrado a Dr. Gerwin Westfield como Vicepresidente Senior de Asuntos Científicos, con efecto a partir del 30 de junio de 2025. El Dr. Westfield, ex ejecutivo de Aytu y colaborador en el premio Nobel, supervisará las estrategias médicas y científicas, enfocándose en el lanzamiento comercial de EXXUA™.
EXXUA, un tratamiento novedoso aprobado por la FDA para el trastorno depresivo mayor (MDD), se lanzará en el cuarto trimestre de 2025. Como el primer agonista selectivo del receptor de serotonina 5HT1a de su clase, EXXUA competirá en el mercado estadounidense de prescripciones para MDD de 22 mil millones de dólares. Cabe destacar que es el único antidepresivo que actúa sobre la serotonina sin advertencias de disfunción sexual, y ha sido probado en más de 5,000 pacientes.
Aytu BioPharma (Nasdaq:AYTU)는 2025년 6월 30일부로 Dr. Gerwin Westfield를 과학 업무 수석 부사장으로 임명했습니다. Westfield 박사는 이전에 Aytu의 임원이자 노벨상 공로자로서, 의료 및 과학 업무 전략을 총괄하며 EXXUA™의 상업적 출시를 중점적으로 담당할 예정입니다.
EXXUA는 주요 우울장애(MDD)를 위한 새로운 FDA 승인 치료제로, 2025년 4분기에 출시될 예정입니다. 5HT1a 세로토닌 수용체 선택적 작용제 중 최초로 출시되는 이 약물은 220억 달러 규모의 미국 처방 MDD 시장에서 경쟁할 것입니다. 특히, 성기능 장애 경고가 없는 유일한 세로토닌 타겟 항우울제이며, 5,000명 이상의 환자를 대상으로 임상 시험이 진행되었습니다.
Aytu BioPharma (Nasdaq:AYTU) a nommé Dr. Gerwin Westfield au poste de Vice-Président Senior des Affaires Scientifiques, à compter du 30 juin 2025. Le Dr Westfield, ancien cadre d'Aytu et contributeur au prix Nobel, supervisera les stratégies médicales et scientifiques, en se concentrant sur le lancement commercial de EXXUA™.
EXXUA, un nouveau traitement approuvé par la FDA pour le trouble dépressif majeur (MDD), sera lancé au quatrième trimestre 2025. En tant que premier agoniste sélectif du récepteur sérotoninergique 5HT1a de sa catégorie, EXXUA concurrencera sur le marché américain des prescriptions pour le MDD, évalué à 22 milliards de dollars. Il est à noter que c'est le seul antidépresseur ciblant la sérotonine sans avertissements liés à la dysfonction sexuelle, et il a été testé sur plus de 5 000 patients.
Aytu BioPharma (Nasdaq:AYTU) hat Dr. Gerwin Westfield zum Senior Vice President für Wissenschaftliche Angelegenheiten ernannt, wirksam ab dem 30. Juni 2025. Dr. Westfield, ein ehemaliger Aytu-Führungskraft und Nobelpreisträger-Mitwirkender, wird die medizinischen und wissenschaftlichen Strategien leiten, mit Fokus auf den kommerziellen Start von EXXUA™.
EXXUA, eine neuartige von der FDA zugelassene Behandlung für Major Depression (MDD), soll im vierten Quartal 2025 auf den Markt kommen. Als erster selektiver Serotonin-5HT1a-Rezeptor-Agonist seiner Klasse wird EXXUA im 22-Milliarden-Dollar-Markt für verschreibungspflichtige MDD-Medikamente in den USA konkurrieren. Bemerkenswert ist, dass es das einzige Antidepressivum ist, das auf Serotonin abzielt und keine Warnhinweise bezüglich sexueller Dysfunktion aufweist, und es wurde an über 5.000 Patienten getestet.
- EXXUA targets $22 billion U.S. prescription MDD market opportunity
- Only antidepressant without sexual dysfunction warnings on label
- Extensive clinical testing with over 5,000 patients
- No significant adverse effects on weight, blood pressure, heart rate or liver function
- Appointment of highly qualified executive with Nobel Prize-contributing work
- None.
DENVER, CO / ACCESS Newswire / June 25, 2025 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, today announced the appointment of Dr. Gerwin Westfield, PhD as Senior Vice President of Scientific Affairs, effective June 30, 2025. In his role, Dr. Westfield will oversee the Company's medical and scientific affairs strategies, with a primary focus on the upcoming commercial launch of EXXUA™ (gepirone) extended-release tablets ("EXXUA"), a novel, branded, United States Food and Drug Administration ("FDA") approved treatment for major depressive disorder ("MDD") in adults in the United States.
Dr. Westfield, a distinguished leader in the medical and pharmaceutical fields whose work has contributed to a Nobel Prize, previously served with the Company from 2015 to 2021, including as Director of Medical Affairs. Most recently, he was Vice President of Medical Affairs for Everly Health, a private, venture-backed healthcare company. His expertise is in
directing essential products, trials, and services within the pharmaceutical and healthcare industry, including medical and scientific affairs, patient advocacy and partnering with regulatory affairs, business development, and sales and marketing. Dr. Westfield received a PhD in Biological Chemistry and B.S. in Biology from the University of Michigan. Dr. Westfield is credited with over twenty peer-reviewed publications and white papers, numerous poster presentations and professional lectures, and has won multiple prestigious academic awards and fellowships.
The Company anticipates launching EXXUA in the fourth calendar quarter of 2025 as a centerpiece of its commercial efforts. Gepirone is a new chemical entity, and EXXUA is the first-in-class selective serotonin 5HT1a receptor agonist approved by the FDA for the treatment of MDD in adults. EXXUA has been extensively studied in over 5,000 patients and represents a new class of therapeutics to compete in the over
"We are excited to welcome Dr. Westfield back to Aytu as we prepare for the commercial launch of EXXUA," said Josh Disbrow, Chief Executive Officer of Aytu. "His deep expertise, proven scientific leadership, and passion for advancing patient care have always been a perfect fit for our vision. Having him rejoin our team is a testament to the strength of our culture and our shared commitment to enhancing the lives of individuals affected by psychiatric conditions with our innovative treatments for MDD and ADHD and ensuring broad access for those who need them most," Disbrow continued.
About Aytu BioPharma
Aytu is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients. The Company's prescription products include EXXUA™ (gepirone) extended-release tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of major depressive disorder (MDD), Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), and a line of legacy products, including Karbinal® ER (carbinoxamine maleate), Poly-Vi-Flor® and Tri-Vi-Flor®. To learn more, please visit aytubio.com.
About EXXUA
EXXUA is a novel oral selective serotonin 5HT1a receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults. EXXUA is also being developed for other psychiatric disorders.
INDICATIONS and IMPORTANT SAFETY INFORMATION for EXXUA
INDICATIONS
EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.
IMPORTANT SAFETY INFORMATION
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.
EXXUA is not approved for use in pediatric patients.
Do not take EXXUA if you:
are allergic to EXXUA or any of the ingredients in EXXUA.
have a prolonged QTc interval greater than 450 msec or congenital long QT syndrome.
are taking medicines known as strong CYP3A4 inhibitors. Ask your healthcare provider if you are not sure if you are taking one of these medicines.
have severe liver problems.
are taking, or have stopped taking within the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.
Do not start taking an MAOI for at least 14 days after you have stopped treatment with EXXUA.
EXXUA may cause serious side effects, including:
Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your levels of body salts (electrolytes) before and during treatment with EXXUA. Your healthcare provider may check your electrolytes more often during treatment if you have heart failure, a slow heart rate, abnormal levels of electrolytes in your blood, or if you take other medications that can prolong the QT interval of your heartbeat.
A potentially life-threatening problem called serotonin syndrome can happen when EXXUA is taken with certain other medicines.
Manic episodes may happen in people with bipolar disorder who take EXXUA.
Please read FULL PRESCRIBING INFORMATION for EXXUA.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by introductory words such as "anticipate," "believe," "expects," "intends," "may," "plan," "should," "subject to," "will," "would" or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include statements regarding the anticipated launch timing for EXXUA and its future commercial prospects, and Aytu's plans related to the commercialization of EXXUA and other Aytu products. For such statements, Aytu claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Aytu's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering, and those factors disclosed in Aytu's filings with the SEC, including its Annual Report on Form 10-K filed on September 26, 2024, and its Quarterly Reports on Form 10-Q. These forward-looking statements represent Aytu's judgment as of the time of this release. Aytu disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contacts for Investors
Ryan Selhorn, Chief Financial Officer
Aytu BioPharma, Inc.
rselhorn@aytubio.com
Robert Blum or Roger Weiss
Lytham Partners
aytu@lythampartners.com
SOURCE: Aytu BioPharma, Inc.
View the original press release on ACCESS Newswire
FAQ
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