Ramelteon

Busy is getting candid about navigating her ADHD diagnosis and treatment experience with Qelbree®The percentage of women newly diagnosed with ADHD between 23-29 and 30-49 years of age nearly doubled in just two years (2020-2022)1Although symptoms are present in childhood, a significant portion of women with ADHD don’t receive a diagnosis until they are adults2 ROCKVILLE, Md., May 01, 2024 (GLOBE NEWSWIRE) -- Actress, author, podcaster, and mother of two, Busy Philipps is teaming up with Supernus Pharmaceuticals to share her personal journey with attention-deficit/hyperactivity disorder (ADHD) – one of the most common psychiatric diagnoses in adults – as well as her experience with Qelbree (viloxazine extended-release capsules), a non-stimulant medication for the treatment of ADHD.3 Busy has been vocal about her personal experience living with ADHD for years, but now she is revealing what it means to be a woman navigating ADHD and wants other women who may be struggling to know they are not alone. Boys are two times more likely than girls to be diagnosed.4 While boys’ symptoms often fit the stereotypical ideas of hyperactive ADHD, girls’ inattentive symptoms are often overlooked. As a result, ADHD often goes undiagnosed in young girls, leading to more adult females being undiagnosed and therefore untreated – a sentiment reflective of Busy’s own experience.2,5 “As women, we tend to mask or overcompensate for our ADHD symptoms and end up working harder to get things done. With the right medication, there’s a sense of relief for women with ADHD – you’re suddenly able to take a deep breath," says Busy. "Since I started treatment with Qelbree, I have been able to better manage my ADHD symptoms and understand what to prioritize versus what can be put on the backburner. I'm excited to collaborate with Supernus as a woman navigating ADHD and shed light on the importance of finding the right treatment by empowering others facing similar challenges.” The partnership comes just in time for Mental Health Awareness Month, an important moment to raise awareness around mental health conditions and overall wellness – including approximately 10 million adults living with ADHD in the United States.3 "Supernus seeks to encourage and lift up those living with ADHD to talk to their doctor about managing and treating their condition, especially during Mental Health Awareness Month,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We’re excited to see that more women with ADHD, including Busy, are able to manage their ADHD symptoms with the help of Qelbree.” For more information about Qelbree, visit Qelbree.com. Patients should speak to a doctor about all the medications they take, and to see if Qelbree could be right for them. INDICATIONQelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATIONQelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. You or your child should not take Qelbree if you or your child:Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline. Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs. Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania. Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired. The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning, for Qelbree here. 1Russell, J., et al. (2023). Number of ADHD Patients Rising, Especially Among Women. Epic Research.2Holthe, M. E. G., Langvik, E. (2017). The Strives, Struggles, and Successes of Women Diagnosed with ADHD as Adults. SAGE Journals.3Culpepper, L., Mattingly, G. (2010). Challenges in Identifying and Managing Attention-Deficit/Hyperactivity Disorder in Adults in the Primary Care Setting: A Review of the Literature. Primary Care Companion Journal of Clinical Psychiatry.4Reuben C., Elgaddal N. (2024) Attention-deficit/hyperactivity disorder in children ages 5–17 years: United States, 2020–2022. NCHS Data Brief, no 499. Hyattsville, MD: National Center for Health Statistics.5Quinn, P. O., Madhoo, M. (2014). A Review of Attention Deficit/Hyperactivity Disorder in Women and Girls: Uncovering This Hidden Diagnosis. Prim Care Companion CNS Disord. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.Tel: (301) 838-2591 Or INVESTOR CONTACT: Peter VozzoICR WestwickeOffice: (443) 213-0505Email: Peter.Vozzo@westwicke.com MEDIA CONTACT: Heidi Donato Tel: (516) 359-1146Email: Heidi.Donato@bcw-global.com

Pictured: Red and white Takeda sign on a brick wall/iStock, jetcityimage Takeda’s work in its orexin franchise may soon reach a new high point as the oral candidate TAK-816 will imminently have a readout in Phase II to treat narcolepsy. Back in 2021, the Japanese pharma put the kibosh on another orexin candidate, TAK-994, due to issues around safety. But with a readout expected soon, Elena Koundourakis, who has led Takeda’s orexin program for more than three years, spoke to BioSpace in San Francisco to talk about what’s to come for its orexin program. This interview has been edited for brevity. BSp: What has been your involvement in Takeda’s orexin program? EK: I’ve been with the company a long time, but I came to orexin after various roles in oncology, GI, and vaccines because I saw the promise of the biology. I knew at the time that orexin was being developed by Takeda since 2017 [as an] IV for narcolepsy, type one and type two. Still, I knew that orexin had been implicated in sleep-wake from a biological perspective, regulation of sleep-wake, respiration, metabolism. BSp: What is the previous history of this drug? EK: It has the potential to serve [an] unmet need in several indications, so that attracted me. . . . We had experience in the sleep field with ramelteon [Rozerem], which was launched in Japan and the U.S. [It] didn’t do extremely well, but it helped us from a chemistry perspective to make the target druggable in terms of having a selective orexin 2 agonist that can penetrate the blood-brain barrier and then modulate the receptor, which is intact in patients with narcolepsy type 1. The peptide is lost . . . but the receptors are intact. So the idea is that you can modulate the receptor, then influence the signaling downstream of the receptor and restore, if you like, the physiological function of patients in narcolepsy. The cardinal symptom is excessive daytime sleepiness, so they often fall asleep throughout the day. BSp: What went wrong with the other orexin program, and how is Takeda aiming to bounce back? EK: We bounced back big time. Because it was the first time we were going from an IV to an oral [drug], we had a lot of question marks. When you try to improve the pathophysiology of a narcoleptic patient who in the morning is somewhat sleepy but not really sleepy, and then in the afternoon is sleepy, and then it gets better later in the afternoon. Still, then they are having disrupted nighttime sleep. It is an oral compound, which you dose maybe once a day or two times a day—it’s hard, right? We weren’t sure if, with the oral TAK-994 at that time, [we could] address all the symptoms. . . . So we have had a very active backup programs. [After toxicity issues ended the program] everybody working on 994 started working on TAK-861. BSp: Even though 994 didn’t progress, results were still posted in the New England Journal of Medicine. What were the most surprising results? EK: The most surprising result that we found was how well it worked. It was like a complete normalization of wakefulness; they wouldn’t fall asleep. Their wakefulness would be like yours and mine—maybe not during J.P. Morgan. Then there’s the complete suppression of cataplexy, like zero cataplectic attacks, which was incredible. . . . So it’s a functional cure, basically. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.