Aquestive Therapeutics, Inc. engages in the identifying, developing, and commercializing differentiated products to address unmet medical needs and to solve patients’ therapeutic problems. Its product pipeline include Libervant, AQST-108, AQST-305, Suboxone and Zuplenz. The company was founded in January 2004 and is headquartered in Warren, NJ.
相关临床试验
9
0 进行中
药物批准
1
批准总数
监管机构
1
监管机构数
成立时间
2004
已完成
7
77.8%
终止
1
11.1%
撤回
1
11.1%
- Aquestive Therapeutics has resubmitted its New Drug Application to the FDA for Anaphylm (dibutepinephrine) sublingual film for Type I allergic reactions, including anaphylaxis. - The resubmission follows a January 30, 2026 Complete Response Letter requesting a human factors study on packaging and administration plus a confirmatory pharmacokinetic study. - Revised packaging cut median pouch-opening time from 17 seconds to 3 seconds, and no protocol-defined use errors occurred in the self-administration arm of the PK study. - The FDA will determine the resubmission classification and set the applicable review timeline after its initial review of the filing.
- Aquestive Therapeutics completed a $150 million debt refinancing with Oaktree Capital Management, providing financial flexibility for the potential launch of Anaphylm, an investigational sublingual film for severe allergic reactions. - The structured financing includes $55 million at closing, with additional tranches of $20 million upon FDA approval, $25 million based on sales milestones, and up to $50 million with mutual consent. - Anaphylm represents a novel epinephrine prodrug delivery system designed as a postage stamp-sized sublingual film that dissolves on contact without requiring water or swallowing. - The refinancing reduces Aquestive's principal debt repayments from $45 million to zero over the next three years while lowering interest rates compared to the previous debt agreement.
- A phase 1 study of 32 pediatric patients aged 7-17 years demonstrated that Anaphylm sublingual epinephrine film achieved pharmacokinetic and pharmacodynamic profiles comparable to those previously observed in adults. - The sublingual film produced a maximum epinephrine concentration of 568.6 pg/mL in children compared to 470.2 pg/mL in adults, with faster time to peak concentration (10 minutes vs 12 minutes). - Treatment-emergent adverse events occurred in 84.4% of pediatric participants but were predominantly mild and self-resolving, with safety profiles consistent with adult populations. - The needle-free delivery system offers a potential alternative to traditional epinephrine auto-injectors for managing anaphylaxis in children weighing at least 30 kg.
- Aquestive Therapeutics is expanding Anaphylm's regulatory pathway globally, planning submissions to Health Canada in the first half of 2026 and Europe in the second half of 2026. - The European Medicines Agency provided positive feedback indicating no additional clinical trials are needed prior to regulatory approval submission for the sublingual epinephrine film. - The company maintains approximately $120 million in cash and cash equivalents, which management believes is sufficient to complete Anaphylm approval and launch processes in the U.S. while advancing international markets. - Anaphylm represents a potential first-in-class oral epinephrine delivery system for severe allergic reactions, designed as a postage stamp-sized sublingual film that dissolves without water or swallowing.
- Aquestive Therapeutics announced a $75 million strategic funding agreement with RTW Investments to support the commercial launch of Anaphylm, contingent on FDA approval. - Anaphylm is positioned as potentially the first and only oral rescue medication for severe allergic reactions including anaphylaxis, offering a novel alternative to injectable treatments. - The funding will provide critical capital through 2027 and includes a tiered single-digit percentage of annual net sales in the U.S. for type I allergic reactions treatment. - Anaphylm features a postage stamp-sized sublingual film format that dissolves on contact without requiring water or swallowing, packaged in a credit card-thin carrier.
- The U.S. District Court for the District of Columbia ruled that the FDA's "indication-specific" interpretation of orphan drug exclusivity violates federal law, marking the second such defeat for the agency. - The court held that Neurelis's VALTOCO exclusivity for acute repetitive seizures blocks approval of Aquestive's competing Libervant across all age groups, not just the originally approved population. - The FDA has appealed the decision to the D.C. Circuit, with briefing scheduled through November 2024, while orphan drug sponsors face continued uncertainty about exclusivity scope. - The ruling reinforces the "disease-specific" interpretation established in the 2022 Catalyst decision, potentially affecting how pharmaceutical companies develop rare disease therapies.
- DelveInsight's 2025 pipeline analysis reveals over 75 companies actively developing more than 90 therapeutic candidates for epilepsy treatment, indicating a dynamic and expanding research landscape. - Recent regulatory milestones include Alembic's FDA approval for generic Depakote Sprinkle and Aquestive Therapeutics receiving seven years of orphan drug exclusivity for Libervant buccal film for pediatric seizure clusters. - Leading pipeline candidates include EPX-100 from Harmony Biosciences in Phase III development, along with promising therapies like BMB-101, STK-001, NRTX-1001, and IAMA-6 in various clinical stages. - The pipeline encompasses diverse therapeutic approaches including monoclonal antibodies, small molecules, and peptides, delivered through multiple administration routes from oral to intravenous formulations.
- The U.S. Food and Drug Administration has approved Aquestive Therapeutics' New Drug Application for Anaphylm, a sublingual epinephrine product for treating severe allergic reactions. - Anaphylm represents a non-device-based alternative to traditional autoinjectors like EpiPen and Auvi-Q, offering wallet portability and rapid onset for emergency anaphylaxis treatment. - The FDA has set a Prescription Drug User Fee Act date of January 31, 2026, with the product positioned to capture market share in a $2 billion addressable market. - Clinical data demonstrates that Anaphylm achieves outcomes comparable to existing autoinjector products while providing unique sublingual administration advantages over nasal spray formulations.
- Phase 2 trial demonstrates that Anaphylm maintains its pharmacokinetic and pharmacodynamic profiles in patients with Oral Allergy Syndrome, showing comparable or superior effectiveness to intramuscular epinephrine. - Study participants experienced rapid symptom resolution within 12 minutes of Anaphylm administration, compared to 74 minutes without intervention, with angioedema symptoms resolving in approximately 5 minutes. - Research led by Aquestive Therapeutics provides crucial evidence that oral physiological changes during allergic reactions do not compromise Anaphylm's therapeutic effectiveness.
- Aquestive Therapeutics is on track to submit its NDA for Anaphylm sublingual film in Q1 2025, aiming to provide the first orally delivered epinephrine for severe allergic reactions. - The company is actively recruiting for the Anaphylm pediatric clinical trial, expanding access to this potential treatment across different age groups. - Aquestive's AQST-108 topical gel completed a pre-IND meeting with the FDA and is set to begin a Phase 2a trial for alopecia areata in Q2 2025.
