Issue link: https://www.e-digitaleditions.com/i/1491587
Recent news about companies that support development of orally inhaled and nasal drug products, including regulatory approvals, new indications for OINDPs and results of clinical studies. News on R&D and progress in the treatment of respiratory diseases, such as asthma and COPD. 8 February 2023 Inhalation son announced results from its ESCAPE- TRD study—a long- term, randomized, open-label Phase IIIb clinical trial designed to evaluate the short-term and long- term efficacy, safety and tolerability of its Spravato (esketamine) nasal spray. The study evaluated 676 adults in total, all of whom have major depressive disorder (TRD) and compared esketamine to ex- isting treatment quetiapine, both in combination with a continu- ing selective serotonin reuptake inhibitor or serotonin and a nor- epinephrine reuptake inhibitor. Esketamine met its primary end- point, showing superior efficacy in achieving remission at week eight compared to quetiapine. It also met its key secondary endpoint, with more participants reaching remission at week eight and re- maining relapse-free up to week 32. "Achieving remission and re- maining relapse-free are major milestones in the treatment of depression and are especially chal- lenging in TRD, where patients have not responded to previous therapies," explained Professor Andreas Reif of Janssen, who led the trial. "This provides further evidence for the use of esketamine nasal spray in this difficult-to-treat population and offers hope for mil- lions of people." Experic expands analytical laboratory facilities, capabilities CRANBURY, NEW JERSEY— Experic announced the expansion of its analytical laboratory and ser- vices. e new 3,800-square-foot laboratory is located in the same office park as the company's head- quarters in Cranbury, New Jersey, US. "It became imperative to ex- pand the laboratory," said Justin Lacombe, PhD, chief scientific officer. "Analytical services are in- tegral to every development project and drug substance." Experic is making additional investments in equipment and software to further support clients who use its formu- lation, development and GMP manufacturing services. e com- pany works across a range of dosing and packaging formats, including low-dose dry powder inhalation. RESPIRATORY MEDICINE NEWS Majority of Scots asthma deaths are in women ABERDEEN, UNITED KING- DOM—e Asthma and Allergy Foundation, based in Aberdeen, announced that 96 Scots died of asthma in 2021, 64 of whom (67 percent) were women, according to Aberdeen Live. ey also stated there were 1,162 asthma deaths in Scotland from 2011 to 2021. "At least half of [the 96 deaths] could have been prevented with better education, awareness and control over treatment. Toxic air, child poverty and poor housing are all massive factors in the un- acceptable situation," said Martina Chukwuma-Ezike, chief executive of the foundation. "We desperately need to re-imagine policy responses which are meaningful and address the root causes." In November 2022, the Asthma and Allergy Foundation held a policy confer- ence that brought together health experts, politicians, patients and those most affected by inequalities in asthma care in Scotland. Sched- uled speakers included Professor Timothy Hinks of Oxford Univer- sity, who is conducting research to determine why women are dying from asthma in greater numbers than men. Asthma and Allergy Foundation in Aberdeen supports Lauren's Law ABERDEEN, UNITED KING- DOM—According to Press and Journal, the Asthma and Allergy Foundation, an Aberdeen health charity, has announced its sup- port for Lauren's Law, a mother's petition to the United Kingdom government for the inclusion of emergency inhalers in first aid kits INDUSTRY NEWS First-in-class in US, SABA/ICS pMDI receives FDA approval C A M B R I D G E , U N I T E D KING DOM—AstraZeneca an- nounced that Airsupra™ (albuterol/ budesonide), formerly known as PT027, has been approved in the United States for the as-needed treatment or prevention of bron- choconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. In the US, Airsupra is a first-in-class, pressurized metered dose inhaler (pMDI), fixed-dose combina- tion rescue medication containing albuterol, a short-acting beta 2 - agonist (SABA) and budesonide, an anti-inflammatory inhaled corticosteroid (ICS). Jointly devel- oped by AstraZeneca and Avillion, it uses AstraZeneca's Aerosphere delivery technology. "Current al- buterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma," said Bradley E. Chipps, past president of the American College of Allergy, Asthma and Im- munology and medical director of Capital Allergy & Respiratory Dis- ease Center, Sacramento, CA, US. "e approval of Airsupra means that for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease." Avillion has been responsible for execut- ing and funding the multicenter, global clinical trial through NDA filing to a regulatory decision in the US. Following the successful approval of Airsupra, AstraZeneca has the option to commercialize the medicine in the US. Janssen nasal spray for depressive therapy demonstrates superior efficacy BEERSE, BELGIUM—Pharma Ti m e s r e p o r t e d t h e Ja n s s e n Companies of Johnson & John- continued on page 34