Latest news with #Qelbree
Yahoo
02-06-2025
- Health
- Yahoo
State investigators visited Richard L. Bean Juvenile Detention Center in April
Investigators with the state's watchdog agency conducted interviews at the Richard L. Bean Juvenile Detention Center on April 7, Knox News has learned. Tennessee Comptroller of the Treasury investigators talked to the facility's only nurse, Stefani Clowers, for an hour and a half that day. One month later, Bean, the superintendent of the facility named for him, gave Clowers a choice: Resign or be fired for "turning him in," she told Knox News. Clowers, a registered nurse, sounded alarms that facility leaders failed to follow medical best practices. She told Knox News she contacted six local and state agencies about errors in medication distribution and several instances where she felt children's lives were in danger. She repeatedly raised concerns to Bean and his lieutenant, Kay McClain, she said. Clowers refused to resign, was fired and then reinstated a day later under pressure from Knox County Mayor Glenn Jacobs and Juvenile Court Judge Tim Irwin, who warned Bean his dismissals of Clowers and information technology specialists Thomas Cordell exposed the county to potential lawsuits that could cost hundreds of thousands of dollars. Cordell also took the offer for reinstatement. Medication intended for the juveniles incarcerated at the facility regularly went missing, Clowers told Knox News, especially when she returned to work on Mondays after being away for the weekend. An entire bottle of Qelbree, a nonstimulant used to treat attention-deficit/hyperactivity disorder, was stolen, she said. Two types of medication belonging to another juvenile went missing for almost a month before showing up unused. "Mom brought them in as new meds on Oct. 4 and then they showed up on (Oct. 27) with the original receipt that she had brought them in on Oct. 4," Clowers said. "I reached out to the worker and verified they were brought in on the 4th. Where'd they go? They disappeared for 23 days." One time, in early 2024 when a tablet of hydrocodone prescribed for a juvenile went missing, Bean and McClain simply thanked Clowers for informing them, Clowers said. Hydrocone is a semisynthetic opioid that can be habit forming and its distribution is rigorously regulated by medical professionals. Before state watchdog investigators came to the facility April 7, no one followed up on Clowers' concerns, she said. Bean and McClain repeatedly ignored requests from Clowers to create a uniform medical protocol. "You can't say, 'There's going to be accountability here, but we're not going to have accountability here,'" Clowers said. Separate from the comptroller's inquiries, Jacobs asked Gov. Bill Lee on May 29 to direct the Department of Children's Services to take over operations at the facility. The move would buy time for the county to shift legal control to the Knox County Sheriff's Office, and the Knox County Commission will consider at its June 23 meeting an emergency measure to do so. Bean announced his retirement May 30 in a press release. Trustee Board member Billy Stokes said Bean told the chair of the facility's board of trustees that a "loss of confidence" in his administration "hastened his intent to retire." Clowers said she was confused when investigators arrived at the center. It's not like "comptroller of the treasury" is a widely known agency, she said. Ten investigators spent most of the day at the detention center, Clowers said, and Bean gave them a tour. Besides the time investigators spent interviewing her and the center's Prison Rape Elimination Act specialist, they spent most of their time in the administrative part of the building. Investigators asked Clowers about patients' medical charts, if there were specific cases they should examine, and how day-to-day operations such as recordkeeping and patient checkups were handled. When Bean fired Clowers, she said he referenced her cooperation with state investigators. Clowers worried about the safety of the children and teens in the center's care (the facility holds juveniles from the ages of 12-17). When children arrived at the detention center, they didn't go through a medical intake process. Those who came to the detention center through the Department of Children's Services arrived with a packet of medical information, Clowers said, but not those who were brought in by local police. Clowers told Knox News that only McClain, Bean's lieutenant, had access the medical packets from Department of Children's Services detainees. The only way Clowers could treat a detainee was if the child initiated a request through a handwritten request that was left in an unsecured basket. Bean, 84, has been the superintendent of the detention center since 1972. He's known for his old-fashioned way of running the center. Day-to-day operations are archaic, Clowers said. There's no buildingwide medical protocol, Clowers told Knox News. Hours worked are tracked through punch cards, and when Clowers requested time off, she filled out a form and left it in a basket. "You just take the day off and then you get the slip of paper back later," Clowers said. In her absence, no qualified medical staffers stepped in to treat juveniles, she said. A corrections officer fills in. "It's just so archaic, it's hard to explain to someone else," Clowers said. Allie Feinberg reports on politics for Knox News. Email her: and follow her on X, formerly known as Twitter, @alliefeinberg. This article originally appeared on Knoxville News Sentinel: State investigators visited Richard L. Bean Juvenile Detention Center
Yahoo
07-05-2025
- Business
- Yahoo
Supernus Pharmaceuticals Inc (SUPN) Q1 2025 Earnings Call Highlights: Strong Revenue Growth ...
The company reported a GAAP net loss of $11.8 million for the first quarter of 2025, compared to net earnings in the prior year quarter. Combined net sales of legacy products Trokendi XR and Oxtellar XR were down 46% in the first quarter, with further erosion expected throughout 2025. The company is advancing its CNS pipeline with plans to initiate a Phase 2b trial for SPN-820 in major depressive disorders, indicating a commitment to R&D and future growth. Qelbree prescriptions grew by 22% and net sales increased by 44% in the first quarter, with a record high of 75,277 monthly prescriptions in March. Story Continues Q & A Highlights Q: Could you please remind us of the key growth drivers for Qelbree in 2025? Is it more about volume or price? Also, could you provide more color on your decision to move forward with SPN-820 in major depressive disorder (MDD)? A: The growth for Qelbree will be driven by both volume and a small price increase. We are optimistic about Qelbree's performance, with prescriptions reaching an all-time high in March. Regarding SPN-820, we expect a placebo-adjusted efficacy delta of five to eight points in MDD, which is clinically significant. We aim to start the study by year-end, with data expected in about a year and a half, depending on recruitment speed. Q: How did normal seasonality impact Qelbree's net pricing in Q1, and what should we expect for the rest of the year? Also, can you comment on the infrastructure for ONAPGO and the timing from start forms to patient prescriptions? A: Q1 typically sees pressure on gross-to-net, with gross-to-net in the early 50s. We expect improvement in Q2 and Q3 unless unforeseen issues arise. We are comfortable with the consensus of $290 million for Qelbree. For ONAPGO, the infrastructure is well-established, and we are optimistic about processing patient enrollment forms efficiently, with conversion rates better than industry average. Q: Could you provide more details on reimbursement discussions for ONAPGO and its differentiation from competitors like the [Habsiz Pump]? A: We expect a high percentage of enrollment forms to be fulfilled, supported by our established infrastructure. ONAPGO offers continuous infusion of apomorphine, a potent dopamine agonist, providing a clear differentiation from Levodopa/Carbidopa pumps. It can be used as an add-on, unlike other pumps, which is a potential advantage. Q: What are you hearing about competitive dynamics for ONAPGO versus [ALIV] and [ABBIE] products? Also, could SPN-443 be used for sleep-wake disorders like narcolepsy? A: Initial feedback for ONAPGO is positive, with strong receptivity from physicians. The differentiation lies in its use of apomorphine, which can be an add-on to existing treatments. For SPN-443, we are considering it for ADHD with potential schedule four classification, but other indications, including sleep-wake disorders, are also being evaluated. Q: Do you have a sense of the proportion of naive patients starting Qelbree for ADHD, and has the combination use in adults changed? A: About 32-33% of Qelbree patients are naive, with the rest being switches, mainly from stimulants. Combination use in adults remains around 35-40%, and we are monitoring if this changes as more data becomes available. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
27-01-2025
- Health
- Yahoo
Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree®, Including New Pharmacodynamic Data and Information for Breastfeeding Women
Updated label includes new data in Section 12.2, detailing serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition, highlighting Qelbree's multimodal pharmacodynamics Qelbree is the first ADHD treatment to meet its post marketing requirement and receive labeling approval following the 2019 FDA guidance on Clinical Lactation Studies1 ROCKVILLE, Md., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2. The updated label describes viloxazine's partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. Additionally, the updated label now includes new lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD), showing that the transfer of Qelbree into breastmilk is low. Qelbree is approved for use in patients ages 6 years and older with ADHD. 'This label update and new data deepens our understanding of Qelbree, providing valuable insights to help support treatment decision-making for people living with ADHD,' says Dr. Stephen M. Stahl, M.D., PhD, DSc (Hon.) Distinguished Health Sciences Clinical Professor of Psychiatry and Neuroscience, University of California Riverside and Adjunct Professor of Psychiatry, University of California San Diego. 'The updated pharmacodynamic data, which highlights viloxazine's effects on the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, adds depth to our understanding of Qelbree's multimodal pharmacodynamics.' The update to include lactation data in the label (Section 8.2) follows the 2019 FDA guidance suggesting lactation studies be conducted to inform breastfeeding with drug use recommendations and is based on a study involving 15 healthy lactating women.¹ The study evaluated the secretion of viloxazine and its metabolite (5-HVLX-gluc) into breast milk following a multi-dose (600 mg daily for three days) regimen of viloxazine. Results showed that the estimated daily infant dose (using a nominal infant body weight of 6 kg) of viloxazine and 5-HVLX-gluc was 0.085 mg/kg and 0.00595 mg/kg, respectively, and the relative infant dose was approximately 1% and 0.07%, respectively, of the weight-normalized maternal daily dose (8.58 mg/kg) of viloxazine. These data support that the transfer of viloxazine into breastmilk is low. The study did not specifically evaluate the effects of viloxazine on breastfed infants or milk production, nor is there additional data regarding these effects. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Qelbree and any potential adverse effects on the breastfed child from Qelbree or from the underlying maternal condition. 'By expanding Qelbree's label to include new data on the pharmacodynamics and use in breastfeeding mothers, Supernus continues to empower healthcare providers and patients to make informed treatment decisions,' says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. 'We are committed to building the body of evidence surrounding Qelbree's use within the ADHD space and providing an effective treatment option for those living with ADHD.' INDICATION Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older. IMPORTANT SAFETY INFORMATION Qelbree 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 or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning and Medication Guide, for Qelbree here. ¹U.S. Food and Drug Administration. (2019). Clinical Lactation Studies: Considerations for Study Design. Guidance for Industry. Retrieved from 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 attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson's Disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, epilepsy, migraine, cervical dystonia, and chronic sialorrhea. 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 Forward Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company's reporting on preliminary and exploratory open label clinical study on SPN-820, the Company's ability to sustain and increase its profitability; the Company's ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company's corporate strategy; the Company's future financial performance and projected expenditures; the Company's ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company's ability to increase net revenue; the Company's ability to commercialize its products and the products of its subsidiaries; the Company's ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company's ability to conduct and progress product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates including SPN-820 and SPN-830; the Company's ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company's expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company's product candidates including SPN-820; the accuracy of the Company's estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company's ability to increase its manufacturing capabilities for its products and product candidates including SPN-820; the Company's projected markets and growth in markets; the Company's product formulations and patient needs and potential funding sources; the Company's staffing needs; and other risk factors set forth from time to time in the Company's filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.(301) 838-2591 Or INVESTOR CONTACT: Peter VozzoICR Healthcare(443) MEDIA CONTACT: Catherine Fabiano(646)
