[Translation] A clinical study of the efficacy and safety of Adasuve for the acute control of agitation in adult patients with schizophrenia or bipolar disorder

比较洛沙平吸入粉雾剂单量给药系统和安慰剂用于精神分裂症或双相障碍成人患者激越的急性控制有效性和安全性；

[Translation]

To compare the efficacy and safety of loxapine single-dose inhalation powder system with placebo for the acute control of agitation in adults with schizophrenia or bipolar disorder;

Start Date29 Apr 2020

Sponsor / Collaborator

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

NCT03110900

/ TerminatedPhase 4IIT

A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation

The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Start Date30 Sep 2017

Sponsor / Collaborator

The University of Arkansas

[+1]

EUCTR2016-004884-38-ES

/ CompletedPhase 4IIT

Prospective naturalistic clinical trail with loxapine in agitated patients with personality disorder

Start Date13 Sep 2017

Sponsor / Collaborator

Vall d'Hebron University Hospital

100 Clinical Results associated with Loxapine

100 Translational Medicine associated with Loxapine

100 Patents (Medical) associated with Loxapine

685

Literatures (Medical) associated with Loxapine

01 Jun 2026·COMPREHENSIVE PSYCHIATRY

Real-world effectiveness of antipsychotic polytherapy on rehospitalization in psychotic disorders: A French nationwide cohort analysis

Article

Author: Cals-Maurette, Mallory ; Bournane, Riad ; Panes, Arnaud ; Schmidt, Aurélie ; Falissard, Bruno ; Nuss, Philippe ; Baloche, Emmanuelle ; Llorca, Pierre-Michel

BACKGROUND:

Antipsychotic polytherapy (APP) is common in clinical practice for psychotic disorders. Previous studies suggest that APP may offer advantages over monotherapy (APM) regarding effectiveness and all-cause discontinuation. This nationwide study assessed the reproducibility and robustness of these findings. The primary objective was to compare psychiatric readmission rates between APP and APM in psychotic disorder patients METHODS: Data were extracted from the French National Health insurance database (SNDS). Patients aged 18 or older with at least one psychiatric hospitalization between 1 January 2014 and 31 December 2020 were included. The primary outcome was time to psychiatric readmission. A within-individual study design was applied to limit confounding, by comparing periods with different treatment exposures within the same patient FINDINGS: A total of 234,959 adults with at least one hospitalization for a psychotic condition were included, with a median follow-up of 7 years. Antipsychotic treatment was associated with a (20%-50%) reduction in psychiatric readmission risk compared with no treatment. Rehospitalization remained common (71.6%). The median cumulative rehospitalization duration was 67 days, and 21.8% of patients had more than four admissions. Among the 71.1% exposed to APP, several combinations demonstrated distinct benefits. Clozapine-inclusive combinations (with risperidone or amisulpride) and loxapine-amisulpride combinations reduced rehospitalization risk. Quetiapine combinations also lowered risk by (10%- 20%) compared with quetiapine monotherapy INTERPRETATION: Derived from a large cohort, our findings corroborate previous evidence that APP's benefit reduces psychiatric rehospitalization and support its utility for psychotic specific patient subpopulations. This study confirms the reproducibility and robustness of APP's effectiveness in real-world settings.

16 Apr 2026·Current Neuropharmacology

Potassium Channelopathies and Precision Medicine Approaches in Epilepsy: A Systematic Review of Personalized Treatment Strategies

Article

Author: Kessi, Miriam ; Yin, Fei ; Peng, Jing ; Xie, Changning

Objective::

This systematic review aimed to summarize recent progress in precision medicine for all studied potassium gene variants related to epilepsy. It analyzed studies conducted in cell and animal models and in humans.

Methods::

A comprehensive search was conducted on PubMed, Embase, and Cochrane databases for all years up to 2025.

Results::

Approximately 2257 papers were reviewed, but only 60 met the inclusion criteria: KCNT1 [n = 38], KCNQ2 [n = 10], KCNQ5 [n = 1], KCNB1 [n = 1], KCNA2 [n = 3], KCNA1 [n = 2], KCNA3 [n = 1], KCNT2 [n = 2], and KCNC1 [n = 2]. Therapies that appear effective for some patients with KCNT1 variants include quinidine, cannabidiol, fluoxetine, and carvedilol. Potential treatments supported by cell and/or animal models include bepridil and antisense oligonucleotide therapy. There is currently no precision therapy for KCNT2 variants; however, potential treatments supported by cell model evidence include quinidine, fluoxetine, loxapine, and riluzole. Emerging potential therapies for KCNQ2-related epilepsy include ezogabine, gabapentin, retigabine, donepezil, amitriptyline, linopirdine, pynegabine, SF0034, and XEN1101. Retigabine and gabapentin are potential therapies for KCNQ5 variants. Cannabidiol is a potential therapy for KCNB1 variants. 4-Aminopyridine is useful for KCNA1 and KCNA2 variants. Gapmer antisense oligonucleotides are a potential treatment for KCNA2 variants. Fluoxetine is a potential therapy for KCNA3 variants. Fluoxetine and compound RE01 are the potential therapies for KCNC1 variants.

Conclusion::

These studies collectively offer valuable insights into precision medicines for genetic epilepsy caused by pathogenic potassium variants. This review is essential because it informs clinical decision-making, including the selection of antiepileptic drugs, thereby supporting its integration into routine clinical care for this population. However, the low level of evidence and the heterogeneity of data from the included studies limit the review.

01 Feb 2026·ENCEPHALE-REVUE DE PSYCHIATRIE CLINIQUE BIOLOGIQUE ET THERAPEUTIQUE

Coprescription of antipsychotics and benzodiazepines at hospital discharge

Article

Author: Thiec, Julie ; Queuille, Emmanuelle ; Tournier, Marie ; Richaud, Alexandre ; Salvo, Francesco ; Debruyne, Anne-Laure ; Demourgues, Maxime ; Guillemin, Sacha

INTRODUCTION:

Antipsychotics and benzodiazepines (BZD) are known to increase the risk of sedation, dizziness, cognitive impairment and even confusion when used in combination because of their psycholeptic properties. Antipsychotics and BZD coprescription should therefore be minor at discharge from a psychiatric hospital, especially for conventional sedative antipsychotics (CS-AP), such as cyamemazine, levomepromazine, or loxapine which are often used as adjunctive treatments like BZD.

OBJECTIVES:

The primary objective was to investigate the prevalence of prescription of CS-AP, long-term antipsychotics (LT-AP), and BZD among patients discharged from hospitalization in psychiatry. The secondary objective was to assess factors associated with CS-AP and BZD coprescription.

MATERIAL AND METHODS:

A retrospective study was conducted by collecting all discharge prescriptions from patients discharged from a psychiatric hospital in 2022 and 2023. To assess prevalence, antipsychotic and BZD use was registered when at least one medication from these classes was prescribed at discharge. Multivariate logistic regression analysis was used to assess factors associated with CS-AP and BZD coprescription. Sensitivity analyses were performed to corroborate our results.

RESULTS:

In total, 5,733 psychiatric stays were associated with prescribed medications at discharge, corresponding to 4,131 different patients. Mean age was 39.8 (±18.7) years. Women represented 56.3% of the studied population. The prevalence of psychotropic drugs on discharge prescriptions was 38.7% for CS-AP, 69.1% for LT-AP, and 48.3% for BZD. The most prescribed drugs, respectively for CS-AP, LT-AP, and BZD, were cyamemazine (24.3% of prescriptions), aripiprazole (16.2%), and diazepam (24.7%). Prevalence of CS-AP+BZD and CS-AP+LT-AP+BZD coprescriptions was respectively 14.8% and 10.1%. After adjustment for age, sex, mode of admission, length of stay class, and prescription of at least one LT-AP at discharge, the CS-AP+BZD coprescription at discharge was associated with two factors: length of hospital stay≤14 days and an initial admission to a psychiatric emergency department (aOR: 1.35, 95% CI [1.14; 1.59], and aOR: 1.23, 95% CI [1.05; 1.45], respectively). Sensitivity analyses showed a similar trend, although results were not always statistically significant.

DISCUSSION:

Our results highlight the importance of an effective hospital-to-community care transition to optimize psycholeptic treatments and minimize the risk of adverse drug reactions in outpatient settings. Cyamemazine was the most prescribed CS-AP at discharge, probably due to its anxiolytic properties. This trend raises concerns regarding its appropriateness when combined with other anxiolytic treatments, such as BZD. The association between CS-AP+BZD coprescription and length of stay<14 days shows that the short hospitalization may hinder proper adaptation of pharmacological treatments. The association between CS-AP+BZD coprescription and initial admission to a psychiatric emergency department may reflect insufficient re-evaluation of the coprescribed drugs probably introduced during acute crisis management. However, our study has several limitations, including reliance on our classification of CS-AP and BZD, and lack of data on key confounders such as diagnoses, seriousness of the acute episode, prior treatments, and post-discharge care.

CONCLUSION:

Prevalence of CS-AP with BZD is high at discharge from a psychiatric hospital, especially in patients with short hospital stays (≤14 days).

News (Medical) associated with Loxapine

11 Dec 2025

·www.prnewswire.com

Lee's Pharmaceutical Holdings Limited Acquires Staccato® One Breath Technology® Platform and Assets, Driving Pipeline Expansion and Advancing Global Partnership with UCB Through Acquired Rights

Acquisition of Staccato® One Breath Technology®, a proprietary platform technology with broad therapeutic potential Synergistic and complementary to Lee's Pharm's existing products pipeline, and Acquisition of rights as licensor and manufacturer of Staccato® alprazolam under a global partnership with UCB HONG KONG, Dec. 11, 2025 /PRNewswire/ -- Nova Pneuma Inc. ("NPI"), the Delaware incorporated and wholly owned subsidiary of Lee's Pharmaceutical Holdings Limited (0950.HK) ("Lee's Pharm" or the "Company"), announced today the assets acquisition from Alexza Pharmaceuticals, Inc. ("Alexza"). The transaction grants Lee's Pharm and NPI, the full ownership of the Staccato® One Breath Technology® ("Staccato® OBT®") platform and assets in relation to Staccato® OBT®, including intellectual property, know-how, trademarks, product pipeline, equipment, products and access to GMP facility, and Alexza's right as licensor and manufacturer of Staccato® alprazolam. This strategic move strengthens Lee's Pharm's aerosolized inhalation drug delivery capabilities, expands the Company's inhalation product pipeline, and aligns with the Company's global expansion strategy. Continue Reading GMP Facility, Fremont CA The transaction remains subject to certain closing conditions and is expected to close by the end of 2025. Proprietary And Well-Validated Staccato® One Breath Technology® The acquisition of the Staccato® OBT® platform represents a major step forward for the Company, granting full ownership of this technology platform which is a well-validated and proven platform supported by approved product, Adasuve®, and several Staccato® based late-stage development programs. This strategic move strengthens the Company's drug delivery capabilities and positions it to drive future innovation in inhalation therapeutics. Synergistic and Complementary to Lee's Pharm's Existing Products Pipeline The transaction also delivers significant synergies with the Company's existing pipeline. The Company has been advancing its clinical development of Staccato® based medicine for cancer-related breakthrough pain and started commercializing Adasuve® for acute agitation in adult schizophrenia or bipolar I disorder across Greater China. Upon completion of the acquisition, all licensing payment obligations payable thereafter by Lee's Pharm to Alexza for the development and commercialization of Staccato® based medicine and Adasuve®, will be eliminated, delivering immediate cost savings and enhancing overall deal economics. In addition, two promising CNS pipeline assets targeting Parkinson's disease and Cyclic Vomiting Syndrome (CVS), both at Phase 2 clinical stage, will be integrated into the Company's portfolio, unlocking new commercial opportunities. Acquisition of Rights as Licensor and Manufacturer of Staccato® alprazolam Under a Global Partnership With UCB Complementing these benefits, the Company acquires Alexza's rights and obligations under the existing worldwide licensing and manufacturing supply agreement with UCB, a biopharmaceutical with strong presence in epilepsy treatment. Under this agreement, UCB holds and will keep global development and commercialization rights for Staccato® alprazolam, which is currently in Phase 3 clinical trial (CinicalTrial.gov ID: NCT05077904), reinforcing the clinical maturity and commercial potential of the Staccato® OBT® platform. UCB acquired Engaged Therapeutics, Inc. for Staccato® alprazolam in June 2020 and entered into an updated license and related commercial supply agreement with Alexza.[1] Subject to achieving specified development, regulatory, and sales milestones, Lee's Pharm together with NPI may receive milestone payments totalling up to US$60.5 million, along with tiered royalties on global net sales of Staccato® alprazolam, in addition to manufacturing revenue from worldwide supply of Staccato® alprazolam. Note: [1] Source of reference: "Acquiring the Staccato® OBT® platform is a transformative step for Lee's Pharm, reinforcing our commitment to innovation in inhalation therapeutics targeting CNS and neurodegenerative disorders, and expanding our global footprint." said Dr. Benjamin Li, Founder and Director of Lee's Pharmaceutical Holdings Limited. "This transaction not only strengthens our pipeline and inhalation R&D capabilities but also creates new revenue streams through the strategic partnerships with UCB." " We are delighted to partner with UCB as it commits and advances solutions to address critical unmet needs in epileptic seizure therapy. This transaction not only delivers near-term financial benefits but also positions us for sustained growth in high-value therapeutic areas, marking a significant milestone in the Company's global expansion strategy." said Ms. Wanee Lee, Managing Director of Lee's Pharmaceutical Holdings Limited. "Under the new leadership, our team is energized to continue collaborating closely with UCB and to ensure the reliable manufacture of meaningful therapy for patients with significant unmet needs. We are equally excited about the opportunity to bring additional Staccato® based medicines to patients around the world, strengthening our shared commitment to improving lives through innovative science." said Dr. Wolfgang Schmidt, SVP Manufacturing and Operations at NPI. About Lee's Pharmaceutical Holdings Limited The Company is a research-driven and market-oriented biopharmaceutical company with more than over 30 years of operation' experience in the pharmaceutical industry in China. The Company is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing based in Mainland China with global perspectives. The Company has established extensive partnerships with around 30 international companies and currently markets over 25 proprietary, generic and licensed-in pharmaceutical products in Mainland China, Hong Kong, Macau and Taiwan. The Company focuses on several key disease therapeutic areas such as cardiovascular health, woman's health, paediatrics, rare diseases, oncology, dermatology and obstetrics. More information available at . About Staccato® One Breath Technology® The Staccato® One Breath Technology® is a unique and highly differentiated drug delivery technology that delivers excipient free drug as fast as intra-venous injection, but non-invasively, resulting in rapid onset of therapeutic effect. It is best positioned for treatment of acute conditions that require quick relief. The ability of the technology with the combination of different molecules to give response to unmet medical needs in an innovative manner has been well proven in large number of clinical studies with different compounds and across number of indications. The proprietary technology is well protected by large numbers of patents across different therapeutic areas. More information available at . 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License out/inAcquisitionPhase 3

29 Mar 2023

·www.biospace.com

IntelGenx Reports Fourth Quarter and Full-Year 2022 Financial Results

SAINT LAURENT, Quebec, March 29, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the three- and twelve-month periods ended December 31, 2022. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise. "The progress we made throughout 2022 has led us to now being potentially on the cusp of a stage of anticipated rapid growth,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “In April, we expect the FDA’s decisions on the Buprenorphine Buccal Film ANDA, as well as the RIZAFILM® NDA. On the development front, we are also looking forward to atai announcing topline results from its Phase 1 clinical trial of Buccal VLS-01, the first ever in-human clinical study evaluating an all thin film psychedelic drug candidate.” 2022 Fourth Quarter Financial Highlights: Revenue was $173,000, compared to $494,000 in the 2021 fourth quarter, mostly due to one-time licensing revenue received in 2021. Net comprehensive loss was $2.3 million, compared to $2.9 million in the 2021 fourth quarter. Adjusted EBITDA loss was $2.3 million, essentially unchanged from Q4-2021. 2022 Full-Year Financial Highlights: Revenue was $1.0 million, compared to $1.5 million in 2021, mostly due to one-time licensing revenue received in 2021. Net comprehensive loss was $11.6 million, compared to $9.8 million in 2021. Adjusted EBITDA loss was $8.5 million, compared to $7.1 million in 2021. Fourth Quarter and Recent Developments: Received a fourth and final term loan tranche in the amount of $3.0 million pursuant to the amended and restated secured loan agreement with the Company’s strategic partner, atai Life Sciences (“atai’). Closed a private placement offering of convertible notes due March 1, 2027 for aggregate gross proceeds of approximately $760,000 (C$1 million). Received from the U.S. Food and Drug Administration (‘FDA”) a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the Agency’s review of the 505(b)(2) New Drug Application (“NDA”) for RIZAFILM® VersaFilm®. Participated in the 35th Annual ROTH Conference in Dana Point, California. Granted a Notice of Allowance for U.S. Patent Application 16/053,383, entitled "Loxapine Film Oral Dosage Form,” from the United States Patent and Trademark Office. Entered into a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled clinical study to investigate the use of Montelukast VersaFilm® for the treatment of Parkinson’s Disease. Entered into an exclusive supply agreement for RIZAPORT® with ARWAN Pharmaceuticals Industries Lebanon s.a.l. in various countries in the Middle East and North Africa region. Entered into a research collaboration with the University of Prince Edward Island to assess palatability, owner-perceived acceptability, and ease of administration of the Company’s VetaFilm™ platform in healthy dogs and cats. Financial Results: Total revenues for the three-month period ended December 31, 2022 amounted to $173,000, a decrease of $321,000, or 65%, compared to $494,000 for the three-month period ended December 31, 2021. The change is mainly attributable to decreases in revenues from licensing agreements of $249,000, R&D revenues of $43,000 and product revenues of $36,000, offset partially by an increase in royalties on product sales of $7,000. Operating costs and expenses were $2.7 million for the fourth quarter of 2022, versus $3.0 million for the corresponding three-month period of 2021. For Q4-2022, the Company had an operating loss of $2.5 million, essentially unchanged from the operating loss for the comparable period of 2021. Net comprehensive loss was $2.3 million, or $0.01 per basic and diluted share, for the fourth quarter of 2022, compared to net comprehensive loss of $2.9 million, or $0.02 per basic and diluted share, for the comparable period of 2021. Total revenues for the twelve-month period ended December 31, 2022 amounted to $1.0 million, representing a decrease of $585,000, or 38%, compared to $1.5 million for the year ended December 31, 2021. Operating costs and expenses were $10.4 million for the full year 2022, versus $9.5 million for the corresponding twelve-month period of 2021. For the twelve-month period of 2022, the Company had an operating loss of $9.4 million, compared to an operating loss of $8.0 million for the comparable period of 2021. Net comprehensive loss was $11.6 million, or $0.07 per basic and diluted share, for the twelve-month period of 2022, compared to net comprehensive loss of $9.8 million, or $0.07 per basic and diluted share, for the comparable period of 2021. As at December 31, 2022, the Company's cash and short-term investments totalled $2.5 million, which did not include the $3.0 million secured loan granted to IntelGenx Corp. by atai in January 2023, nor the $760,000 in gross proceeds from the private placement offering of convertible notes, which closed in March 2023. Annual Filings: The Company's annual report on Form 10-K and financial statements for the year ended December 31, 2022, as well as the 2023 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 29, 2023. Conference Call Details: IntelGenx will host a conference call to discuss these 2022 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0062 (Canada and the United States) or (973) 528-0011 (International); access code 884881. The call will be also be webcast live and archived on the Company's website at under "Webcasts" in the Investors section. About IntelGenx IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films. IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions. IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit . Forward-Looking Information and Statements This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at , and also filed with Canadian securities regulatory authorities at . IntelGenx assumes no obligation to update any such forward-looking statements. Source: IntelGenx Technologies Corp. For IntelGenx: Stephen Kilmer Investor Relations (647) 872-4849 stephen@kilmerlucas.com Or Andre Godin, CPA, CA President and CFO IntelGenx Corp. (514) 331-7440 ext 203 andre@intelgenx.com

Phase 1Financial Statement

29 Jun 2022

·www.biospace.com

Elite Pharmaceuticals, Inc. Reports Financial Results for the Fiscal Year Ended March 31, 2022 and Provides Conference Call Information

Conference Call Scheduled for Thursday, June 30 at 11:30 AM EDT NORTHVALE, NJ / ACCESSWIRE / June 29, 2022 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, announced results for the fiscal year ended March 31, 2022 ("Fiscal 2022"). Consolidated revenues for Fiscal 2022 were $32.3 million, an increase of $6.9 million or 27% as compared to the comparable period of the prior fiscal year. The increase was primarily attributed to revenues from generic immediate-release Adderall®, generic extended-release Adderall®, generic Loxapine Capsules, and strong revenues relating to Naltrexone Tablets sales. Operating profits were $5.1 million, an increase of $3.0 million from the comparable period of the prior year, and net income was $8.9 million. Conference Call Information Elite's management will host a conference call to discuss the year-end 2022 financial results and provide an update on recent business developments. Stockholder questions should be submitted to the company in advance of the call. Date: June 30, 2022 Time: 11:30 AM EDT Dial-in numbers: 1-800-346-7359 (domestic) 1-973-528-0008 (international) Conference number: 98840 Questions: dianne@elitepharma.com Financial questions by 7:00 PM EST on Wednesday, June 29, 2022 Audio Replay: The financial statements can be viewed for Elite's Year 2022 on Form 10-K here. About Elite Pharmaceuticals, Inc. Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Prasco, LLC, Epic Pharma, LLC, and TAGI Pharma. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit . This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA, and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. Contact: For Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations, 518-398-6222 Dianne@elitepharma.com SOURCE: Elite Pharmaceuticals, Inc. View source version on accesswire.com:

Financial Statement

100 Deals associated with Loxapine

External Link

KEGG	Wiki	ATC	Drug Bank
D02340	Loxapine	N05AH01	DB00408

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Agitation	European Union	Ferrer Internacional SA	20 Feb 2013
Agitation	Iceland	Ferrer Internacional SA	20 Feb 2013
Agitation	Liechtenstein	Ferrer Internacional SA	20 Feb 2013
Agitation	Norway	Ferrer Internacional SA	20 Feb 2013
Bipolar Disorder	European Union	Ferrer Internacional SA	20 Feb 2013
Bipolar Disorder	Iceland	Ferrer Internacional SA	20 Feb 2013
Bipolar Disorder	Liechtenstein	Ferrer Internacional SA	20 Feb 2013
Bipolar Disorder	Norway	Ferrer Internacional SA	20 Feb 2013
Bipolar I disorder	United States	Nova Pneuma Inc.	21 Dec 2012
Schizophrenia	United States	Nova Pneuma Inc.	21 Dec 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute migraine	Phase 2	United States	Alexza Pharmaceuticals, Inc.	01 Jun 2007
Migraine Disorders	Phase 2	United States	Alexza Pharmaceuticals, Inc.	01 Jun 2007
Migraine With Aura	Phase 2	United States	Alexza Pharmaceuticals, Inc.	01 Jun 2007
Asthma	Phase 1	United States	Alexza Pharmaceuticals, Inc.	01 May 2009
Psychotic Disorders	Phase 1	United States	Alexza Pharmaceuticals, Inc.	01 Oct 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00444028 (CTgov)	Phase 1	Schizophrenia	50	Staccato Loxapine (Staccato Loxapine 0.625 mg)	fstzslvffe(vvbokxdvej) = vrefvrtbxa hrvqvzdjfh (affjwjcrez, 21.3) View more	-	20 Nov 2018
				Staccato Loxapine (Staccato Loxapine 1.25 mg)	fstzslvffe(vvbokxdvej) = eppyqoflcu hrvqvzdjfh (affjwjcrez, 1.31) View more
NCT03110900 (loxapine, CTgov)	Phase 4	Drug intoxication \| Psychomotor Agitation \| Agitation	2	lorazepam+Haloperidol (Haloperidol + Lorazepam)	qjvmzrgrmr(jyekqdxqcl) = qxbcoeqahg pzxlyxroip (ljgwsfnpxm, byhdhouyha - qxhfhbwjpw) View more	-	11 Jun 2018
				Loxapine (Loxapine)	qjvmzrgrmr(jyekqdxqcl) = nfgscgiwup pzxlyxroip (ljgwsfnpxm, ykckhwaduz - fikvbnzrej) View more
NCT00369577 (CTgov)	Phase 2	Schizophrenia \| Agitation	129	Inhaled Placebo (Inhaled Placebo)	feqntybbla(unyrjqsomq) = akyjoxckdd wddejvlrsk (adzuzemjxk, 4.13) View more	-	02 Jan 2018
				Inhaled Loxapine 5 mg (Inhaled Loxapine 5 mg)	feqntybbla(unyrjqsomq) = auikwlmbwo wddejvlrsk (adzuzemjxk, 5.14) View more
NCT01877642 (CTgov)	Phase 4	-	22	Lorazepam 1 mg IM+Inhaled loxapine 10 mg	ngsqdudrfs(gzydhqqjis) = tzsileufet qxkjjoahnm (lpgplwhhwf, zzjhkupvnf - covzvaxkjn) View more	-	13 Dec 2017
NCT01193816 (Pubmed \| Crit Care)	Phase 4	Agitation	102	Loxapine	wkrdkrierz(yzytxfrjoi) = hnsfuojihs nuutrykstk (toclrlzqqq )	-	06 Sep 2017
				Placebo	wkrdkrierz(yzytxfrjoi) = hbxawuujva nuutrykstk (toclrlzqqq )
NCT00721955 (CTgov)	Phase 3	Bipolar I disorder \| Agitation	314	Inhaled Placebo (Inhaled Placebo)	cjvztdvlvk(rawixssyzr) = rnykcibnig kfhfethhzz (jfvydwgefw, 4.77) View more	-	29 Jun 2017
				Inhaled loxapine 5 mg (Inhaled Loxapine 5 mg)	cjvztdvlvk(rawixssyzr) = gnnynufpgo kfhfethhzz (jfvydwgefw, 4.90) View more
NCT00628589 (CTgov)	Phase 3	Schizophrenia \| Agitation	344	Inhaled placebo (Inhaled Placebo)	nvxgpgdkkj(oohjtgpixd) = uowzvpewao qpnsbdjerw (jjthqdwlxw, 4.92) View more	-	29 Jun 2017
				Inhaled loxapine 5 mg (Inhaled Loxapine 5 mg)	nvxgpgdkkj(oohjtgpixd) = heqqhznmbh qpnsbdjerw (jjthqdwlxw, 5.17) View more
NCT00825500 (CTgov)	Phase 2	Migraine Disorders \| Migraine With Aura \| Acute migraine	366	Inhaled Placebo (Inhaled Placebo)	tkrpssuney = vwrlockoxx ihrkfkvmbu (dpefpbcpna, kcwuzryrrg - jwhoonwsap) View more	-	24 Apr 2017
				Inhaled Loxapine 1.25 mg (Inhaled Loxapine 1.25 mg)	tkrpssuney = vpljlxypme ihrkfkvmbu (dpefpbcpna, prnkmlyrlq - chyddzluql) View more
NCT00489476 (CTgov)	Phase 2	Migraine Disorders \| Migraine With Aura \| Acute migraine	168	Staccato Placebo (Staccato Placebo)	evllpfdvnk = ushdennoug lfdmqgrzyk (ulmmlndpcg, fopzjdiazc - hsrtyefxrc) View more	-	24 Apr 2017
				Staccato Loxapine (1.25 mg Staccato Loxapine)	evllpfdvnk = chctcwozsv lfdmqgrzyk (ulmmlndpcg, shsstescti - bhwvbiexui) View more
NCT00555412 (Pubmed \| J Clin Pharmacol)	Phase 1	Psychotic Disorders	32	Inhaled Loxapine 15 mg	klifftmmqf(pakjvwiyij) = 3 of 32, 9% wkbcgokest (tzvbtguxmw ) View more	-	01 Sep 2015
				Inhaled Loxapine 20 mg

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