CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Dec 17, 2025--
Aptar Group, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, today announced that its Bidose (BDS) Liquid Nasal Spray System is the mechanism for delivering the newly approved CARDAMYST™ (etripamil) Nasal Spray. CARDAMYST received approval by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. The novel treatment was developed by Milestone ® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. This marks Aptar’s first combination of dual Bidose delivery systems housed in a consumer-friendly protective two-pack container.
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An estimated two million people in the United States are currently diagnosed with PSVT, a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute, resulting in an estimated 140,000 to 525,000 Emergency Department visits and 40,000 to 120,000 inpatient hospitalizations in the U.S. each year 1.
Integrated Bidose Device Container Closure System Ensures Reliable Drug Access CARDAMYST is easy to use and is small enough to be conveniently carried by patients for use as directed. Aptar CSP Technologies collaborated with Milestone Pharmaceuticals to develop a custom-designed, patient-friendly polypropylene container closure system with a fully integrated cap for CARDAMYST. This protective dual-container system is designed to securely house two Bidose delivery mechanisms, with features intended to prevent accidental activation or dropping from the container and help promote reliability at the moment of need.
Gael Touya, President of Aptar Pharma, said, “This approval underscores the broadening of Aptar’s drug delivery solutions for more therapeutic areas and the growing demand for nasal drug delivery. We are pleased that our trusted and proven Bidose nasal system, combined with our protective dual-container system, is now available for patients in yet another therapeutic area.”
Alex Theodorakis, President, Aptar Pharma Prescription, added, “After years of close collaboration with Milestone, this successful outcome proves again our capability to support customers globally to develop and launch complex treatments with easy-to-use and reliable systems.”
“Aptar has been an essential partner in developing and delivering a novel treatment for PSVT that fills a serious unmet need. We are proud to partner with a company that shares our commitment to innovation and quality and look forward to working together to provide CARDAMYST to patients,” said Joseph Oliveto, President and CEO, Milestone Pharmaceuticals.
Proven Nasal Drug Delivery Platforms
Aptar’s Bidose (BDS) and Unidose (UDS) systems are designed for intuitive, reliable intranasal administration and for meeting strict U.S. FDA quality standards. Offering effective and proven single or two-shot intranasal delivery for a variety of medicines, these platforms support pharmaceutical partners in developing emergency use treatments.
Accelerated Development Support via Aptar Pharma Services
This innovative treatment for PSVT is another example of a Combination Product submission, and benefited from Aptar Pharma’s Drug Services offering, a comprehensive portfolio of stage-specific development packages. Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to help expedite approval.
About Aptar
Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions 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 over 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in development for the treatment of symptomatic episodic attacks associated with atrial fibrillation with rapid ventricular rate, or AFib-RVR. www.milestonepharma.com
This press release contains forward-looking statements, including regarding the anticipated benefits and performance of Aptar’s Bidose Nasal System in delivering CARDAMYST, expected patient use and adoption, future market opportunities, and our plans with respect to expanding nasal drug delivery solutions into additional therapeutic areas. 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: the successful commercialization and market acceptance of CARDAMYST; our ability to support customers in the development and launch of drug-device combination products; 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.
1PSVT - Areas of Focus - Milestone Pharma
Milestone Pharmaceuticals received U.S. Food and Drug Administration approval of CARDAMYST for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT), commonly called SVT, to sinus rhythm in adults.
The Lumbee Tribe of North Carolina achieved a goal more than a century in the making on Wednesday when it secured federal recognition as a tribal nation through the passage of a defense bill in Congress.
The state-recognized tribe, whose historic and genealogical claims have been called into question by several tribal leaders, has been seeking federal acknowledgement for generations. Congress has considered the issue for more than 30 years, but the effort gained momentum after President Donald Trump endorsed the state-recognized tribe on the campaign trail last year.
Legislation to recognize the Lumbee Tribe had struggled to pass through Congress in recent years, but it was attached to the 2026 National Defense Authorization Act, which was passed by the Senate on Wednesday afternoon. It was unclear when the president would sign it.
“It means a lot because we have been figuring out how to get here for so long,” said Lumbee Tribal Chairman John Lowery moments after celebrating the victory in the office of North Carolina Sen. Thom Tillis. “We have been second-class Natives and we will never be that again, and no one can take it away from us.”
With federal recognition comes a bevy of federal resources, including access to new streams of federal dollars and grants and resources like the Indian Health Service. It also allows the tribe to put land into trust, which gives it more control over things like taxation and economic development, such as a casino.
In the 1980s, the Lumbee Tribe sought recognition through the Office of Federal Acknowledgement within the Interior Department, which evaluates the historical and genealogical claims of tribal applicants. The office declined to accept the application, citing a 1956 act of Congress that acknowledged the Lumbee Tribe but withheld the benefits of federal recognition.
That decision was reversed in 2016, allowing the Lumbee to pursue recognition through the federal administrative process. The tribe instead continued to seek recognition through an act of Congress.
There are 574 federally recognized tribal nations. Since the Office of Federal Acknowledgement was established in 1978, 18 have been approved by the agency, while about two dozen have gained recognition through congressional legislation. Nineteen applications ranging from Maine to Montana are now pending before the agency, with at least one under consideration by Congress.
Once federally recognized, the Lumbee Tribe would become one of the largest tribal nations in the country, with about 60,000 members. Congressional Budget Office estimates have found that providing the tribe with the necessary federal resources would cost hundreds of millions of dollars in the first few years alone.
“Hopefully, Congress will expand the pie in appropriations so that the other tribes, many of which are poor, don’t suffer because there’s suddenly such a larger number of Native Americans in that region," said Kevin Washburn, former assistant secretary of Indian affairs at the Interior Department and a professor at the University of California, Berkeley School of Law.
Over 200 Lumbee members gathered in a gymnasium in Pembroke, North Carolina, to watch the final Senate vote on television. They celebrated with shouts, raised hands and applause as the unofficial tally indicated the bill would receive final congressional approval.
Victor Dial held his 8-month daughter Collins at the celebration. Dial’s grandfather is a late former tribal chairman.
“He told us the importance of this, and he told us this day would happen, but we didn’t know when,” Dial said. “I’m so glad my kids were here to see it.”
Not everyone in Indian Country is celebrating. The move has drawn opposition from some tribal leaders, historians and genealogists who argue that the Lumbee’s claims are unverifiable and that Congress should require the tribe to complete the formal recognition process.
“Federal recognition does not create us — it acknowledges us,” Shawnee Tribe Chief Ben Barnes, an opponent of Lumbee recognition, testified before the Senate last month. He warned against replacing historical documentation with political considerations.
Critics have noted that the Lumbee have a history of shifting claims and previously used different names, including Cherokee Indians of Robeson County, and say the tribe lacks a documented historical language.
“If identity becomes a matter of assertion rather than continuity, then this body will not be recognizing tribes, it will be manufacturing them,” Barnes told lawmakers.
The Lumbee Tribe counters that it descends from a mixture of ancestors “from the Algonquian, Iroquoian and Siouan language families,” according to its website, and notes it has been recognized by North Carolina since 1885.
While the Lumbee Tribe has received bipartisan support over the years, federal recognition became a campaign promise in 2024 for both Trump and Democratic nominee Kamala Harris.
“He kept that promise and showed extraordinary leadership," said Tillis, the Republican senator who introduced a bill to recognize the Lumbee Tribe.
Robeson County, where most Lumbee members live, has shifted politically in recent years. Once dominated by Democrats, the socially conservative area has trended Republican. The Lumbee Tribe's members in North Carolina are an important voting block in the swing state, which Trump won by more than three points.
In January, Trump issued an executive order directing the Interior Department to develop a plan for Lumbee recognition. That plan was submitted to the White House in April, and a department spokesperson said the tribe was advised to pursue recognition through Congress.
Since then, Lowery, the tribal chairman, has worked closely with members of Congress, particularly Tillis, and appealed directly to Trump. In September, Lowery wrote to Trump announcing ancestral ties between the Lumbee Tribe and the president's daughter Tiffany Trump, according to Bloomberg, which first reported on the letter.
Associated Press writers Gary D. Robertson in Raleigh, North Carolina, Allen G. Breed in Pembroke, North Carolina, and Jacquelyn Martin in Washington, D.C., contributed.
John Lowery, N.C. State Rep. and Chairman of the Lumbee Tribe of N.C., center, leads a toast to Sen. Thom Tillis, R-N.C., center, front right, as members of the Lumbee Tribe of North Carolina, celebrate the passage of a bill granting their people federal recognition, on Capitol Hill, in Washington, Wednesday, Dec. 17, 2025. (AP Photo/Jacquelyn Martin)
Austin Curt Thomas, 11, gets a celebratory fist bump from Sen. Thom Tillis, R-N.C., as he and his father Aaron Thomas, of Pembroke, N.C., join fellow members of the Lumbee Tribe of North Carolina, to celebrate after the passage of a bill granting their people federal recognition, on Capitol Hill, in Washington, Wednesday, Dec. 17, 2025. (AP Photo/Jacquelyn Martin)
People celebrate after passage of the National Defense Authorization Act by the U.S. Senate during a watch party hosted by the Lumbee Tribe of North Carolina, Wednesday, Dec. 17, 2025, in Pembroke, N.C. (AP Photo/Allison Joyce)
People celebrate after passage of the National Defense Authorization Act by the U.S. Senate, during a watch party hosted by the Lumbee Tribe of North Carolina, Wednesday, Dec. 17, 2025, in Pembroke, N.C. (AP Photo/Allison Joyce)
FILE - Members of the Lumbee Tribe bow their heads in prayer during the BraveNation Powwow and Gather at UNC Pembroke, March 22, 2025, in Pembroke, N.C. (AP Photo/Allison Joyce, file)
People sing while playing drums during a watch party hosted by the Lumbee Tribe of North Carolina, Wednesday, Dec. 17, 2025, in Pembroke, N.C. (AP Photo/Allison Joyce)
People celebrate after passage of the National Defense Authorization Act by the U.S. Senate during a watch party hosted by the Lumbee Tribe of North Carolina, Wednesday, Dec. 17, 2025, in Pembroke, N.C. (AP Photo/Allison Joyce)
People celebrate after passage of the National Defense Authorization Act by the U.S. Senate during a watch party hosted by the Lumbee Tribe of North Carolina, Wednesday, Dec. 17, 2025, in Pembroke, N.C. (AP Photo/Allison Joyce)
People celebrate after passage of the National Defense Authorization Act by the U.S. Senate, during a watch party hosted by the Lumbee Tribe of North Carolina, Wednesday, Dec. 17, 2025, in Pembroke, N.C. (AP Photo/Allison Joyce)
