Latest news with #AptarPharma
Daily Telegraph
a day ago
- Business
- Daily Telegraph
LTR Pharma completes ED study milestone
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. LTR Pharma & co-development partner Aptar Pharma complete extractables study on SPONTAN All identified compounds below ICH safety thresholds for nasal spray-mist erectile dysfunction treatment Leachables study initiated to support FDA regulatory submission under real-world storage conditions Special Report: LTR Pharma has completed a key extractables study for its SPONTAN intranasal spray for erectile dysfunction and kicked off a leachables study as part of a regulatory development program. LTR Pharma (ASX:LTP) said the extractables study, conducted under the supervision of co-development partner Aptar Pharma, evaluated the bottle and pump components of SPONTAN's container closure system. The study confirmed that all detected compounds were below ICH safety thresholds – the internationally recognised standards adopted by the US Food and Drug Administration (FDA) and regulatory authorities worldwide for pharmaceutical impurities. LTR Pharma said the identified compounds would be monitored in the ongoing leachables study. FDA requires extractables and leachables (E&L) studies for all pharmaceutical products to ensure packaging materials do not compromise product safety or efficacy. For nasal spray products, these studies must meet specific regulatory thresholds due to direct tissue exposure. Leachables study now underway The leachables study has started under Aptar Pharma's management, evaluating the potential migration of the compounds from packaging into SPONTAN under real-world storage conditions. LTR Pharma said SPONTAN used industry-standard bottle and pump components as used in multiple FDA-approved nasal spray products. The study will run for at least 24 months to support shelf-life requirements. Consistent with FDA practice for nasal sprays, the company can submit its application once sufficient robust data is available, with study completion continuing post-approval as standard. E&L studies form part of LTR Pharma's comprehensive regulatory strategy following its FDA pre-IND meeting, where the FDA confirmed the proposed development pathway. The company said E&L data were required for the chemistry, manufacturing and controls (CMC) section of its planned new drug application (NDA). With extractables results meeting regulatory requirements, the company progresses to the leachables phase for comprehensive regulatory submission data. Watch: LTR's new appointment Progress on SPONTAN and new US-targeted ROXUS LTR Pharma continues to progress SPONTAN through established regulatory pathways while building commercial foundations through its Australian early access programs. It is also progressing its new ED nasal spray called ROXUS, which offers a fast-track pathway to serve patients through the US personalised healthcare sector. As with SPONTAN, ROXUS is based on the common active ingredient vardenafil. It will be delivered via the 503(a)-compounding pharmacy pathway, which exempts drugs from the usual approval, labelling and manufacturing requirements. "The completion of our extractables study and commencement of the leachables phase keep our regulatory program on schedule,' LTR Pharma executive chairman Lee Rodne said. 'Working with Aptar Pharma provides us with their established expertise in nasal spray device development and FDA submissions. 'These studies are necessary steps in our development pathway, and we look forward to progressing through each regulatory milestone." This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as LTR Pharma completes study milestone for SPONTAN ED treatment
Yahoo
27-02-2025
- Business
- Yahoo
RDD Europe 2025, Co-Organized by Aptar Pharma and RDD Online, Celebrates 20 Years
CRYSTAL LAKE, Ill., February 27, 2025--(BUSINESS WIRE)--Aptar Pharma, leader in respiratory drug delivery solutions, and RDD Online® are pleased to announce their co-organization of RDD® Europe 2025, which will be held in-person from Tuesday, May 6 to Friday, May 9, 2025 at the Estoril Congress Center in Estoril, Portugal. Celebrating 20 years of RDD Europe and one of the largest and highly regarded international respiratory health conferences, RDD Europe 2025 will host over 500 scientists, engineers, clinicians and business professionals engaged in all aspects of nasal and pulmonary drug delivery. With curated and peer reviewed content organized in six Knowledge Spaces, speakers, workshops, poster presenters and exhibitors will share timely, actionable insights under the following themes: Bench to Bedside: Emerging Therapies and Clinical Advances Inspiring Dry Powder Inhalation: Formulation Science and Device Design MDIs in Transition: Evolving Science and Regulations Advanced Inhalation: AI and Data Driven Design Aqueous Agenda: Soft Mist Inhalers and Nebulizer Advances Nasal Spotlight: Advances in Systemic and Nose-to-Brain Delivery. Twelve delegate-selectable industry Workshops will take place on Wednesday, May 7, providing practical and interactive demonstrations of innovative technologies, products and capabilities in a small group setting. An integrated Poster & Exhibition session will run throughout the 3-day conference, ensuring ample opportunity for networking, with 70 exhibit tables and 72 posters showcasing academic and industry research, and development breakthroughs across established and emerging nasal and pulmonary drug delivery platforms. To complement in-person activities, RDD Europe 2025 will also include extended online access from April 29 to June 30, 2025 to on-demand presentations and company profiles. In addition, almost 3,000 peer-reviewed speaker and poster papers will be available to delegates for 12 months after the conference. The conference will open with a Welcome Cocktail Reception on the evening of Tuesday, May 6, and Aptar Pharma will sponsor a Gala Dinner at a scenic location in Estoril on Thursday, May 8. As a global leader in OINDP device design and technology, Aptar Pharma is proud to be a Co-Organizer of RDD Europe 2025 and will host a workshop on May 7. Entitled "Ready for Clinical Trials in 1 Hour: A Roadmap to Success," this workshop will be co-presented by Jonathan Mulpas, Director Business Development Pulmonary Category, Aptar Pharma, Will Ganley, Manager, Computational Pharmaceutics, Nanopharm, an Aptar Pharma company, and Carolina Dantas, Head of Medical & Scientific Affairs, Pulmotree. "Estoril is a great location to celebrate 20 years of RDD Europe conferences. I can't wait to catch up with friends and organizations who have returned year after year since RDD Europe 2005 was first held in Paris," commented Richard Dalby, one of the conference organizers. "So much has changed since then, and the innovation I've witnessed seems poised to have direct benefits on patient health, healthcare provider choice and environmental sustainability." Added Carolyn Penot, Director of Operational Marketing at Aptar Pharma, "RDD Europe 2025 is a must-attend event, and this year's Knowledge Spaces will represent the latest thinking in nasal and pulmonary drug delivery. We look forward to celebrating 20 years of RDD Europe with our conference participants." To register as a delegate or learn more about sponsorship opportunities, visit the RDD Europe 2025 website. About RDD Online RDD Online manages the organization of Respiratory Drug Delivery conferences in the U.S., and partners with Aptar Pharma to run RDD events in Europe and Asia. These international conferences, focused on technologies and solutions to improve patient health, routinely attract over 500 delegates from 25 countries representing academia, industry and regulatory agencies. RDD Online also supplies realistic mouth throat models, Nephele mixing inlets and dose collection tubes. We offer scientific and technical publications, web-based training, and a company directory of organizations active in pulmonary and nasal drug delivery. For more information, please visit About Aptar Pharma Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar's innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world's leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has approximately 13,000 dedicated employees in 20 countries. For more information, visit View source version on Contacts Media Contact RDD Online, LLCRichard Dalby+1 (804) 239 1978rdalby@ Media Contact Aptar PharmaCiara Jackson+49 1511 951 Sign in to access your portfolio
