Aptar’s Intranasal Delivery System Used in Phase II Clinical Study for Investigational SPONTAN® Nasal Spray

Key Terms

intranasal medical

Administration or delivery of a drug or vaccine through the nose, typically via a spray or drops that are absorbed by the nasal tissues. For investors, intranasal products can matter because they often offer easier, needle-free use, faster onset of effect, and potential cost or compliance advantages that can widen a product’s market and affect regulatory review, manufacturing complexity, and commercial prospects — similar to how a convenient app can outsell a clunky desktop program.

phase ii medical

Phase II is the mid-stage clinical trial where a potential drug or medical treatment is tested in a larger group of patients to see if it works and to help determine the best dose and common side effects. For investors, Phase II results matter because they give the first meaningful evidence about effectiveness and safety—like a road test that shows whether a product has real promise before a much bigger, costly final trial and potential regulatory approval.

pharmacokinetic medical

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

human factors technical

Human factors are the study and design of how people interact with products, processes, and work environments to make tasks safer, easier, and less error-prone. For investors, good human factors practices reduce the risk of accidents, product failures, regulatory penalties and costly rework, and can boost productivity and customer satisfaction — much like a well-designed car dashboard that helps drivers operate controls without distraction.

regulatory pathway regulatory

A regulatory pathway is the official process a product or service must follow to gain approval from government authorities before being offered to the public. It outlines the steps, tests, and reviews needed to demonstrate safety, effectiveness, or compliance. For investors, understanding the regulatory pathway helps assess how quickly and easily a product can reach the market and generate revenue.

Supporting advancement of complex intranasal therapies through clinical development

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)-- AptarGroup, Inc. (NYSE:ATR), a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing, today announced that its proprietary nasal delivery system is being utilized in LTR Pharma Limited’s (ASX:LTP) Phase II clinical study of SPONTAN^®, an investigational intranasal spray under development for the treatment of erectile dysfunction. This milestone reflects Aptar Pharma’s continued commitment to supporting intranasal drug delivery technologies and supporting the development of innovative, patient-centric therapies.

Aptar’s Intranasal Delivery System Utilized in Phase II Clinical Study of SPONTAN® Nasal Spray

LTR Pharma recently announced the dosing of the first patients in the Phase II study of SPONTAN^®, which is evaluating the safety, tolerability and pharmacokinetic profile of LTR Pharma’s rapid acting intranasal spray, supporting continued clinical development and advancement along the regulatory pathway.

Aptar Pharma’s nasal spray platform is a multidose delivery system designed to deliver accurate and consistent dosing of prescription drug products administered via the nose, supporting reliable intranasal administration throughout clinical development.

This collaboration, supported by Aptar Pharma companies Nanopharm and Noble, helps reinforce Aptar Pharma’s position as a trusted partner in advancing complex intranasal therapies through robust delivery platforms and deep regulatory and technical expertise. Nanopharm developed and optimized the formulation to support the intended product profile, supported by analytical services demonstrating drug product and device performance alongside stability, while Noble is delivering end‑to‑end human factors and risk management support to enhance regulatory readiness and validate usability.

Lee Rodne, Executive Chairman of LTR Pharma, said, “As we progress SPONTAN^® through Phase II, robust and reproducible intranasal delivery is central to our development strategy. Partnering with Aptar Pharma provides us with a proven delivery platform supported by deep formulation, analytical and human factors expertise, strengthening the foundation of our clinical and regulatory pathway.”

Alex Theodorakis, President, Aptar Pharma Prescription, added, “Reliable nasal drug delivery is critical as programs move through clinical development, and we are pleased to support LTR Pharma as it advances an innovative intranasal treatment that uses Aptar Pharma’s proprietary delivery technology."

About Aptar

Aptar is a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing. Aptar partners with the world’s top healthcare and consumer brands to deliver medicines and create exceptional user experiences. Serving diverse markets, from pharmaceutical to beauty to food and beverage, Aptar combines market expertise with proprietary design, engineering and science to develop innovative solutions that help improve lives worldwide. Headquartered in Crystal Lake, Illinois, Aptar employs 14,000 dedicated people across 20 countries. Learn more at http://www.aptar.com.

About LTR Pharma

LTR Pharma is a clinical-stage biopharmaceutical company focused on developing innovative intranasal therapies. The Company’s lead asset, SPONTAN^®, is being developed as a rapid-acting intranasal treatment for erectile dysfunction. LTR Pharma is progressing SPONTAN^® through clinical development to support regulatory submissions in key global markets. For more information, visit www.ltrpharma.com.

This press release contains forward-looking statements, including regarding the use of Aptar Pharma’s intranasal spray platform in third-party intranasal clinical development activities and the potential role of such platform in supporting pharmaceutical development programs. Forward-looking statements generally can be identified by the fact that they do not relate strictly to historical or current facts and by use of words such as “expects,” “anticipates,” “believes,” “estimates,” “future,” “potential,” “continues” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results or other events may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: risks related to clinical development activities conducted by third parties; development and commercialization risks; customer adoption; regulatory requirements and compliance; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K and Form 10-Qs. We undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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Source: AptarGroup, Inc.