Delving into the Latest Updates on Loxapine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Loxapine (USAN/INN), Staccato Loxapine

+ [4]

Target

5-HT2A receptor x D2 receptor

Mechanism

5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor antagonists(Dopamine D2 receptor antagonists)

Therapeutic Areas

Other Diseases

Active Indication

AgitationBipolar DisorderBipolar I disorder+ [1]

Inactive Indication

AsthmaMigraine DisordersPsychotic Disorders+ [2]

Originator Organization

Alexza Pharmaceuticals, Inc.

Active Organization

Ferrer Internacional SA

Alexza Pharmaceuticals, Inc.

Inactive Organization

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

US (21 Dec 2012),

Bipolar I disorderSchizophrenia

Regulation-

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Structure/Sequence

Molecular FormulaC18H18ClN3O

InChIKeyXJGVXQDUIWGIRW-UHFFFAOYSA-N

CAS Registry1977-10-2

AIM OF THE STUDYThe past twenty years have seen a rise in cocaine-related statistics in France, including cocaine use in the general population, emergency ward presentations of acute cocaine intoxication, cocaine use disorders related outpatient appointments and cocaine-related deaths. This study's objectives were to describe trends in patients' admission for specific cocaine detoxification as well as changes in patients' characteristics in the Assistance publique-Hôpitaux de Paris (AP-HP) hospitals group located in Paris region, France.METHODSWe reviewed the international classification of diseases 10^th edition (ICD-10) discharge codes of the AP-HP hospitals group between 2011 and 2021. In addition, medical reports of the largest addiction medicine ward were also analysed for changes across the years 2009, 2014, 2019 and 2022.RESULTSThe regional database showed an almost 3-fold increase in cocaine-related disorders discharge codes between 2011 and 2019. This occurred due to a rise in hospital stays for cocaine dependence or cocaine acute intoxication prior to the fall in levels of inpatient stays associated with the coronavirus disease 2019 (COVID-19) pandemic. The in-depth analysis of inpatients' stays in the specialized addiction medicine ward also showed an increase in admissions for cocaine detoxification programs, with a prevalence of 1.19% in 2009 to 15.73% in 2022 (P=1.44×10^-20). Inpatient characteristics showed significant changes, especially in 2022, namely: more daily users, less intravenous administration and less comorbid illicit substances use disorders, with heightened levels of cured hepatitis C patients (P<0.05). Inpatient prescriptions were primarily dopaminergic antagonists with sedatives properties (cyamemazine, loxapine and chlorpromazine), dopamine-receptors partial agonist (aripiprazole) and serotonin reuptake inhibitors.CONCLUSIONThe referral to hospital care for cocaine detoxification has increased in Paris region since 2011, coupled with changes in inpatients' characteristics. This trend has significant implications for the management of inpatient hospital services.

01 Oct 2024·Journal of Ocular Pharmacology and Therapeutics

Survey of Dopamine Receptor D2 Antagonists as Retinal Antifibrotics

Article

Author: Saraf, Namita ; Gao, Ashley Y. ; Haak, Andrew J. ; Whaley, Madison G. ; Bakri, Sophie J.

Purpose: To evaluate the potency and efficacy of a library of dopamine receptor D2 (D2R) antagonists in the mitigation of fibrotic activation in retinal pigment epithelial (RPE) cells. Methods: ARPE-19 cells were cultured and treated with methotrexate or 27 district D2R antagonists using a fibronectin deposition assay. The most potent compounds were then further assessed in assays measuring cellular proliferation, cellular migration, and profibrotic gene expression. Results: The previously established antifibrotic D2R antagonist loxapine exerted a robust and dose-dependent inhibition of fibronectin deposition, whereas methotrexate exerted minimal inhibition. The most potent D2R antagonist identified, fluphenazine, effectively blocked in vitro models of fibrosis at 300-1,000 nM concentrations. Conclusions: Here we found multiple FDA-approved D2R antagonists that potently block RPE cell fibrogenesis. These findings further support the potential of D2R antagonism as a potential therapeutic for retinal fibrotic disease.

01 Apr 2024·International journal of clinical pharmacy

First generation antipsychotic-associated serious adverse events in women: a retrospective analysis of a pharmacovigilance database.

Article

Author: Leppien, Emily E ; Piper, Brian J ; Naik, Heeral ; Doughty, Bennett J ; Bange, Seraphine ; McCall, Kenneth L

BACKGROUNDWomen have been under-represented in trials of antipsychotic medications.AIMOur primary objective was to evaluate five adverse events (AE) associated with first-generation antipsychotics (FGAs) among women relative to men through an analysis of the FDA Adverse Event Reporting System (FAERS).METHODWe queried 24.6 million AE reports from 2000 to 2023 involving FGAs. The study cohort consisted of chlorpromazine (n = 3317), fluphenazine (n = 1124), haloperidol (n = 16,709), loxapine (n = 3151), perphenazine (n = 816), thioridazine (n = 665), thiothixene (n = 244), and trifluoperazine (n = 360). Cases of neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), Torsades de Pointes (TdP), agranulocytosis (AG), and cerebrovascular adverse events (CVAE) were identified. Reporting odds ratios (ROR) and associated 95% confidence intervals (CI) were calculated with logistic regression for each AE among women relative to men.RESULTSA total of 2,857 serious AEs were evaluated in the study cohort (NMS = 1810, TD = 434, TdP = 260, AG = 149, CVAE = 204). The ROR for women compared to men was 0.79 (95% CI, 0.71-0.87) for NMS, 0.83 (0.68-1.01) for TD, 1.21 (0.94-1.53) for TdP, 0.71 (0.51-0.98) for AG, and 0.91 (0.68-1.19) for CVAE. A secondary analysis revealed a higher odds in women compared to men of hospitalization associated with reports of TD (ROR = 1.95, 1.29-2.94) and death associated with reports of AG (ROR = 2.46, 1.15-5.24). A subgroup analysis of haloperidol revealed an ROR = 1.67 (1.26-2.21) for women relative to men for TdP.CONCLUSIONThe subgroup analysis of haloperidol AEs revealed a significantly higher reporting odds ratio for TdP. Additionally, the secondary study findings suggest that women were more vulnerable to worse outcomes associated with certain AEs of FGAs.

2

News (Medical) associated with Loxapine

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

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External Link

KEGG	Wiki	ATC	Drug Bank
D02340	Loxapine	N05AH01	DB00408

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Agitation	NO	Ferrer Internacional SA	20 Feb 2013
Agitation	LI	Ferrer Internacional SA	20 Feb 2013
Agitation	IS	Ferrer Internacional SA	20 Feb 2013
Agitation	EU	Ferrer Internacional SA	20 Feb 2013
Bipolar Disorder	LI	Ferrer Internacional SA	20 Feb 2013
Bipolar Disorder	NO	Ferrer Internacional SA	20 Feb 2013
Bipolar Disorder	IS	Ferrer Internacional SA	20 Feb 2013
Bipolar Disorder	EU	Ferrer Internacional SA	20 Feb 2013
Bipolar I disorder	US	Alexza Pharmaceuticals, Inc.	21 Dec 2012
Schizophrenia	US	Alexza Pharmaceuticals, Inc.	21 Dec 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bipolar Disorder	Preclinical	CN	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	29 Apr 2020
Schizophrenia	Preclinical	CN	Zhaoke Pharmaceutical (Hefei) Co., Ltd.	29 Apr 2020
Pulmonary Disease, Chronic Obstructive	Preclinical	US	Alexza Pharmaceuticals, Inc.	01 Jun 2009
Asthma	Preclinical	US	Alexza Pharmaceuticals, Inc.	01 May 2009
Smoking Cessation	Preclinical	US	Alexza Pharmaceuticals, Inc.	01 Apr 2009
Agitation	Preclinical	US	Alexza Pharmaceuticals, Inc.	01 Feb 2008
Psychotic Disorders	Preclinical	US	Alexza Pharmaceuticals, Inc.	01 Oct 2007
Migraine Disorders	Preclinical	US	Alexza Pharmaceuticals, Inc.	01 Jun 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00789360 (CTgov)	Phase 1	-	30	Loxapine (Inhaled Loxapine)	lmheqeqcdd(nszaxxokgl) = uhexfqcgcc yjuajclpgp (dkqcbnwion, rxfrpzpmfw - njmiljjmat) View more	-	11 Mar 2019
				Staccato Placebo (Inhaled Staccato Placebo)	lmheqeqcdd(nszaxxokgl) = hwnqhkfvqs yjuajclpgp (dkqcbnwion, wxdfpzlznn - vonzzasars)
NCT00444028 (CTgov)	Phase 1	Schizophrenia	50	Staccato Loxapine (Staccato Loxapine 0.625 mg)	(zhhrlobjnw) = nsegcaxeut nzknntvvzq (amfjvvqghq, wmjdzmcqzv - vtxyewskyr) View more	-	20 Nov 2018
				Staccato Loxapine (Staccato Loxapine 1.25 mg)	(zhhrlobjnw) = ykuslhwjdk nzknntvvzq (amfjvvqghq, ewvlzsiudt - vbvkxfvjzk) View more
NCT03110900 (loxapine, CTgov)	Phase 4	Drug intoxication \| Psychomotor Agitation \| Agitation	2	lorazepam+Haloperidol (Haloperidol + Lorazepam)	biomfrlszi(mzvrhikttp) = imphjdvowk txlvrncscx (vptxpzdioi, zifhosjemc - bstrmfoabw) View more	-	11 Jun 2018
				Loxapine (Loxapine)	biomfrlszi(mzvrhikttp) = bmxelouuhd txlvrncscx (vptxpzdioi, riwhuccwej - amjklzbchu) View more
NCT00369577 (CTgov)	Phase 2	Schizophrenia \| Agitation	129	Inhaled Placebo (Inhaled Placebo)	oyruixtcts(lyjdausypf) = ybcvvbugcs xzhmkuxynl (tvzccmbnxj, ripckvzeie - mkpruaprql) View more	-	02 Jan 2018
				Inhaled Loxapine 5 mg (Inhaled Loxapine 5 mg)	oyruixtcts(lyjdausypf) = vgypzisydg xzhmkuxynl (tvzccmbnxj, kgworiabdv - lmxtvmtmjv) View more
NCT01193816 (Pubmed \| Crit Care)	Phase 4	Agitation	102	Loxapine	cseoobkgtg(oerfhsxdtw) = ajoiworwvw bxfyhwwktm (lnjadxqgek )	-	06 Sep 2017
				Placebo	cseoobkgtg(oerfhsxdtw) = iarfssgpaq bxfyhwwktm (lnjadxqgek )
NCT00721955 (CTgov)	Phase 3	Bipolar I disorder \| Agitation	314	Inhaled Placebo (Inhaled Placebo)	(wrovudpdno) = crjnomooey cqnrxojhml (okndylwqjv, pjqnnsarbv - didehzifsi) View more	-	29 Jun 2017
				Inhaled loxapine 5 mg (Inhaled Loxapine 5 mg)	(wrovudpdno) = yifiotmqhd cqnrxojhml (okndylwqjv, wxstgzvkxb - szggqwctym) View more
NCT00628589 (CTgov)	Phase 3	Schizophrenia \| Agitation	344	Inhaled placebo (Inhaled Placebo)	zlanmyyeik(pappuslyyi) = zbqrofzqxw hjkkpooxzi (amqhhfxcud, zfymnobbmo - ddiirmolmj) View more	-	29 Jun 2017
				Inhaled loxapine 5 mg (Inhaled Loxapine 5 mg)	zlanmyyeik(pappuslyyi) = kgwbbhozyk hjkkpooxzi (amqhhfxcud, poeqpyfkyr - zmcwrwatna) View more
NCT00825500 (CTgov)	Phase 2	Migraine Disorders	366	Inhaled Placebo (Inhaled Placebo)	xftlxeqbvs(dslksfrtqx) = ozzusehgje ejmfkyhllh (mmaekvazzk, nbxziinahp - pmryehtxzt) View more	-	24 Apr 2017
				Inhaled Loxapine 1.25 mg (Inhaled Loxapine 1.25 mg)	xftlxeqbvs(dslksfrtqx) = leeclfitwt ejmfkyhllh (mmaekvazzk, dtmgnpnfoi - flzdgolhml) View more
NCT00489476 (CTgov)	Phase 2	Migraine Disorders	168	Staccato Placebo (Staccato Placebo)	kxupqryeqb(kzjdxkhuix) = hxgseydbfp azsguowgty (xlkpljxnfd, irrpvrufok - srmgfrkcgx) View more	-	24 Apr 2017
				Staccato Loxapine (1.25 mg Staccato Loxapine)	kxupqryeqb(kzjdxkhuix) = xkqsbbczdx azsguowgty (xlkpljxnfd, fdkjezioxw - hmvjsgyfvs) View more
NCT00874237 (Pubmed \| J Clin Pharmacol)	Phase 1	-	48	Inhaled placebo	(qdkrcrpcwn) = adadoxdmrx xxefybmxww (cybtkjvhxz ) View more	Negative	01 Jun 2014
				10 mg loxapine	(ypewajaoqq) = ibosezpxlz kaohocrjuv (pfkemkihqq ) View more