A Single Treatment Pharmacokinetic and Safety Study of Natroba (Spinosad) Topical Suspension 0.9% w/w in Subjects 1 Month to 3 Years 11 Months of Age With an Active Scabies Infestation

A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the goal of completing approximately 16 subjects. With assistance from a caregiver, Natroba will be applied over the entire body from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp). The open-label Investigational Product (IP) will remain on the skin for at least 6 hours before removing the IP by gentle washing. The subjects will stay in the clinic until the 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. Safety will be assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose and pre-discharge laboratory evaluations. Following the sample collections subjects will be released from the clinic and directed to their primary care physician for follow-up. Subjects will be provided scabies medications upon discharge to dispense to family members. These include 5% Permethrin for those in the household that are less than 4 years of age and Natroba for those in the household 4 years of age and older. Subjects who terminate early will not be given these medications to dispense to family members.

Start Date04 Mar 2022

Sponsor / Collaborator

ParaPRO LLC

[+5]

NCT02485704 / CompletedPhase 3

A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Natroba™ (Spinosad) for the Treatment of Scabies

To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for the complete cure of scabies after a single treatment.

Start Date10 May 2017

Sponsor / Collaborator

ParaPRO LLC

[+1]

NCT02485717 / CompletedPhase 3

A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy and Pharmacokinetics of Natroba™ (Spinosad) for the Treatment of Scabies

To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for the clinical cure of scabies after a single treatment. The trial will also assess the pharmacokinetics (PK) of spinosad and benzyl alcohol following a single dose of Natroba™ in pediatric subjects 4-16 years of age. These subjects will be a separate population of pediatric subjects.

Start Date02 May 2017

Sponsor / Collaborator

ParaPRO LLC

[+1]

100 Clinical Results associated with Spinosad

100 Translational Medicine associated with Spinosad

100 Patents (Medical) associated with Spinosad

1,012

Literatures (Medical) associated with Spinosad

01 Jan 2025·Synthetic and Systems Biotechnology

Engineering the TetR-family transcriptional regulator XNR_0706 to enhance heterologous spinosad production in Streptomyces albus B4 chassis

Article

Author: Tang, Hao ; Ye, Bang-Ce ; Wei, Wenping ; Wu, Jing ; Wang, Wenzong ; Cui, Xingjun

The TetR family of regulators are an important group of transcription regulators that regulate diverse cellular processes in prokaryotes. In this study, we found that XNR_0706, a TetR family regulator, controlled the expression of XNR_0345, XNR_0454, XNR_0513 and XNR_1438 putatively involved in fatty acid β-oxidation by interacting with the promoter regions in Streptomyces albus B4. The transcription level of these four genes was downregulated in XNR_0706 deletion strain (ΔXNR_0706) and restored by XNR_0706 complementation in Δ0706/pIB-0706, demonstrating that XNR_0706 was a positive transcriptional regulator of the genes. With toxic long-chain fatty acids addition in TSB media, deletion of XNR_0706 caused significantly poor growth, whereas XNR_0706 complementation increased the utilization of additional fatty acids, resulting in restored growth. Fatty acid β-oxidation is one source of acetyl- and malonyl-CoA precursors for polyketides biosynthesis in actinobacteria. Overexpression of XNR_0706 in B4/spnNEW, a spinosad heterologous expression strain derived from S. albus B4, increased spinosad yield by 20.6 %. Additionally, supplement of 0.3 g/L fatty acids resulted in a further 42.4 % increase in spinosad yield. Our study reveals a regulatory mechanism in long-chain fatty acids metabolism in S. albus and these insights into the molecular regulation of β-oxidation by XNR_0706 are instrumental for increasing secondary metabolites in actinobacteria.

01 Jan 2025·COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY C-TOXICOLOGY & PHARMACOLOGY

Ecotoxicity of bioinsecticide spinosad to soil organisms: Commercial formulation versus active ingredient

Article

Author: Antunes, Sara C ; Rodrigues, Sara ; Bouguerra, Sirine ; Antunes, Sara C. ; Nogueira, Verónica ; Moreira, Alexandre

Spintor® (SPIT®) is a commercial formulation of a bioinsecticide with the active ingredient Spinosad (SPIN). Despite the efforts of regulatory agencies, there still is a lack of information regarding short- and long-term exposures to soil-dwellers, as well as effects at environmentally relevant concentrations. This work aimed to evaluate the effects of SPIT® and SPIN, on the oligochaete Eisenia fetida, and the arthropod Folsomia candida. For this, natural soil was spiked with environmentally relevant concentrations (0.00-1.49 mg of the active ingredient·kg^-1 of dry soil) to assess avoidance behaviour in E. fetida and reproduction effects on both species. Further, in E. fetida adults exposed for 2- and 28-day biomarkers of oxidative stress, energetic reserves, neurotoxicity and genotoxicity were evaluated. A significant reduction in juvenile production for F. candida was observed for SPIT® at ≥0.66 mg kg^-1 and SPIN at ≥0.13 mg kg^-1, and although no effect was observed on E. fetida reproduction, the oligochaeta revealed a tendency to avoid soil spiked with SPIT® at 0.44, 0.66 and 1.49 mg kg^-1. The sub-individual responses of E. fetida demonstrate genotoxicity upon exposure to SPIT® and SPIN for 2 days. The 2-day exposures of SPIT® and SPIN seem to induce defence mechanisms, and in general, SPIN exerted higher effects than SPIT® on the oligochaetes. Overall, the pro-oxidant performance and energy metabolism pathways were disrupted in both exposures to SPIT® and SPIN. The results suggest that spinosyns-based products can have an impact on soil arthropods F. candida and oligochaete's health, possibly affecting their essential functions in terrestrial ecosystems.

01 Dec 2024·Synthetic and Systems Biotechnology

Enhanced triacylglycerol metabolism contributes to the efficient biosynthesis of spinosad in Saccharopolyspora spinosa

Article

Author: Yang, Danlu ; Dai, Zirui ; Sun, Lin ; Xia, Liqiu ; Xia, Ziyuan ; Liu, Yangchun ; Jin, Duo ; Zhu, Zirong ; Rang, Jie ; Cao, Li

Triacylglycerol (TAG) is crucial for antibiotic biosynthesis derived from Streptomyces, as it serves as an important carbon source. In this study, the supplementation of exogenous TAG led to a 3.92-fold augmentation in spinosad production. The impact of exogenous TAG on the metabolic network of Saccharopolyspora spinosa were deeply analyzed through comparative proteomics. To optimize TAG metabolism and enhance spinosad biosynthesis, the lipase-encoding genes lip886 and lip385 were overexpressed or co-expressed. The results shown that the yield of spinosad was increased by 0.8-fold and 0.4-fold when lip886 and lip385 genes were overexpressed, respectively. Synergistic co-expression of these genes resulted in a 2.29-fold increase in the yield of spinosad. Remarkably, the combined overexpression of lip886 and lip385 in the presence of exogenous TAG elevated spinosad yields by 5.5-fold, led to a drastic increase in spinosad production from 0.036 g/L to 0.234 g/L. This study underscores the modification of intracellular concentrations of free fatty acids (FFAs), short-chain acyl-CoAs, ATP, and NADPH as mechanisms by which exogenous TAG modulates spinosad biosynthesis. Overall, the findings validate the enhancement of TAG catabolism as a beneficial strategy for optimizing spinosad production and provide foundational insights for engineering secondary metabolite biosynthesis pathways in another Streptomyces.

News (Medical) associated with Spinosad

13 Sep 2024

·www.biospace.com

Cipher Pharmaceuticals Partner Moberg Pharma AB Provides Update on MOB-015 Phase 3 Study

MISSISSAUGA, ON , Sept. 13, 2024 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: CPH) (OTCQX: CPHRF) (“ Cipher ” or the “ Company ”) announced today that its partner, Moberg Pharma AB (“Moberg”), issued a news release earlier today stating that it has received information about clinical cure in a subset of patients in the ongoing North American Phase 3 study for MOB-015, a product for the treatment of nail fungus. Moberg has noted that the number of patients who have achieved clinical cure in this blinded subset of patients is lower than its expectations, which necessitates that Moberg inform the market about this fact. Moberg’s full press release can be found here . Cipher owns the Canadian marketing rights to Moberg’s MOB-015 through a licensing agreement (the “Agreement”) dated September 18, 2018 , to commercialize, promote, sell and distribute the product exclusively in Canada . On signing the Agreement, the Company paid an upfront amount of US$0.5 million and any future additional payments of up to US$14.1 million are contingent upon successful achievement of certain clinical data results as well as development, regulatory and commercial sales milestones. Cipher has no further financial obligations in respect of the Agreement if the applicable development and regulatory milestones outlined in the Agreement are not attained. The Company will continue to collaborate with its partner Moberg as full results from their clinical trial become available, however this pipeline product does not impact the sales and earnings pro Cipher’s existing business today. The Company continues to be focused on its recent acquisition of the Natroba TM business from ParaPRO LLC as announced on July 29, 2024 , as well as other potential growth opportunities. The Company believes the growth potential for the Natroba TM product in the U.S. market and other markets internationally is significant, and the integration of this business into its existing profitable North American platform remains Cipher’s focus and priority in the near term. About Cipher Pharmaceuticals Inc. Cipher Pharmaceuticals (TSX: CPH) (OTCQX: CPHRF) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products, mainly in dermatology. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products in Canada, the U.S., and South America. For more information, visit . Forward-Looking Statements and Non-IFRS Measures This document includes forward-looking statements within the meaning of applicable securities laws. These forward-looking statements include, among others, statements with respect to the clinical studies being conducted by Moberg, the results of such studies and their potential impact on the Company, the Company’s expectations for Natroba TM and the Company’s plans for Natroba TM , our objectives and goals and strategies to achieve those objectives and goals, as well as statements with respect to our beliefs, plans, expectations, anticipations, estimates and intentions. The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”, “hope” and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. By nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, publication of negative results of clinical trials; our ability to enter into development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on a limited number of products; our dependency on protection from patents that will expire; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of certain products; product approval process by regulators which can be highly unpredictable; the timing of completion of clinical trials, regulatory submissions and regulatory approvals; reliance on third parties to manufacture our products and events outside of our control that could adversely impact the ability of our manufacturing partners to supply products to meet our demands; we may be subject to future product liability claims; unexpected product safety or efficacy concerns may arise; we generate license revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive with new competing product entrants; requirements for additional capital to fund future operations; products may be subject to pricing regulation; dependence on key managerial personnel and external collaborators; certain of our products are subject to regulation as controlled substances; limitations on reimbursement in the healthcare industry; extent and impact of health pandemic outbreaks on our business; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; we may be unsuccessful in evaluating material risks involved in completed and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; compliance with privacy and security regulation; our policies regarding product returns, allowances and chargebacks may reduce revenues; additional regulatory burden and controls over financial reporting; general commercial litigation, class actions, other litigation claims and regulatory actions; the difficulty for shareholders to realize in the United States upon judgments of U.S. courts predicated upon civil liability of the Company and its directors and officers who are not residents of the United States ; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent laws; inability to protect our trademarks from infringement; shareholders may be further diluted if we issue securities to raise capital; volatility of our share price; the fact that we have a significant shareholder; our operating results may fluctuate significantly; and our debt obligations will have priority over the common shares of the Company in the event of a liquidation, dissolution or winding up. We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the “Risk Factors” section of our MD&A for the year ended December 31, 2023 and the Company’s Annual Information Form, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language. SOURCE Cipher Pharmaceuticals Inc.

License out/inPhase 3

08 Aug 2024

·cipher.investorroom.com

Cipher Pharmaceuticals Reports Second Quarter 2024 Results

(All figures are presented in U.S. Dollars) MISSISSAUGA, ON, Aug. 8, 2024 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: CPH) (OTCQX: CPHRF) ("Cipher" or the "Company") today announced its financial and operating results for the three and six months ended June 30, 2024. Second Quarter 2024 Financial Highlights (All figures in U.S. dollars, compared to Q2 2023, unless otherwise noted) Acquisition of Natroba Management Commentary Craig Mull, Interim CEO, commented: "Four years ago, the Company embarked on a phased, multi-year strategy to transform Cipher into a profitable and scalable specialty pharmaceutical business. With our base business consistently performing, I am happy to declare that the first phase of this strategy is complete, and Cipher's focus will now shift into a phase of substantial growth. Last week's Natroba Acquisition should be viewed as the kick-off of our growth phase. Cipher's revenue and earnings profile has immediately doubled, further accelerating the overall profitability of the business. Additionally, the Company now possesses a fully established and profitable U.S. platform which will allow us to add complementary dermatology and infectious disease products over time. We presently remain active on a number of business development initiatives in connection with our strategy in building a North American dermatology platform. We are confident our MOB-015 nail fungus pipeline product, whereby we have the exclusive Canadian marketing rights, will drive near term growth to our Canadian business, and bringing Natroba through a Health Canada approval will further accentuate the Canadian product portfolio. Lastly, we will be focusing on out-licensing Natroba globally, as there is a profound resistance issue lice and scabies have developed over time to existing products on the market, and where Natroba fills a true unmet need. We believe the global potential for Natroba will be a significant driver of our growth." Bryan Jacobs, CFO, commented: "I am proud to announce our new partnership with National Bank of Canada as their financial strength and in-depth industry knowledge will be tremendous assets in helping Cipher achieve its growth objectives. We have up to $50 million additional financing under the flexible revolving credit facility to support our continued growth plans. In my transition to President, I will be focused on our newly acquired Natroba commercial operations and working collaboratively with the highly talented commercial team, especially in the indication for scabies where Natroba has only recently obtained an FDA 'complete cure' designation, and whereby we believe there is significant further growth opportunity." Q2 2024 Corporate Highlights Q2 2024 Financial Review (All figures in U.S. dollars, compared to Q2 2023, unless otherwise noted) Business Strategy & Outlook Cipher's near term business strategy includes the following key focuses: Financial Statements and MD&A Cipher's Financial Statements for the three and six months ended June 30, 2024, and Management's Discussion and Analysis (the "MD&A") for the three and six months ended June 30, 2024, are available on the Company's website at www.cipherpharma.com in the "Investors" section under "Financial Reports" and on SEDAR+ at www.sedarplus.ca. Notice of Conference Call Cipher will hold a conference call on August 9, 2024 at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. About Cipher Pharmaceuticals Inc. Cipher Pharmaceuticals (TSX: CPH) (OTCQX: CPHRF) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products, mainly in dermatology. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products in Canada, the U.S., and South America. For more information, visit www.cipherpharma.com. Forward-Looking Statements and Non-IFRS Measures This document includes forward-looking statements within the meaning of applicable securities laws. These forward-looking statements include, among others, statements with respect to the timing of the receipt of the topline results from MOB-015 Phase 3 North American study, the expectation of approval of MOB-015 in the U.S. and Canada, the ParaPRO transaction, our plans and intentions with respect to commercializing, out-licensing and marketing Natroba™ in Canada and elsewhere, our plans and intentions with respect to the introduction of additional dermatological products in Canada, the U.S. and elsewhere, the potential for future acquisitions, our objectives and goals and strategies to achieve those objectives and goals, as well as statements with respect to our beliefs, plans, expectations, anticipations, estimates and intentions. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. By their nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, publication of negative results of clinical trials; our ability to enter into development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on a limited number of products; our dependency on protection from patents that will expire; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of certain products; the product approval process by regulators which can be highly unpredictable; the timing of completion of clinical trials, regulatory submissions and regulatory approvals; reliance on third parties to manufacture our products and events outside of our control that could adversely impact the ability of our manufacturing partners to supply products to meet our demands; we may be subject to future product liability claims; unexpected product safety or efficacy concerns may arise; we generate license revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive with new competing product entrants; requirements for additional capital to fund future operations; products may be subject to pricing regulation; dependence on key managerial personnel and external collaborators; certain of our products are subject to regulation as controlled substances; limitations on reimbursement in the healthcare industry; extent and impact of health pandemic outbreaks on our business; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; we may be unsuccessful in evaluating material risks involved in completed and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; compliance with privacy and security regulation; our policies regarding product returns, allowances and chargebacks may reduce revenues; additional regulatory burden and controls over financial reporting; general commercial litigation, class actions, other litigation claims and regulatory actions; the difficulty for shareholders to realize in the United States upon judgments of U.S. courts predicated upon civil liability of the Company and its directors and officers who are not residents of the United States; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent laws; inability to protect our trademarks from infringement; shareholders may be further diluted if we issue securities to raise capital; volatility of our share price; the fact that we have a significant shareholder; our operating results may fluctuate significantly; and our debt obligations will have priority over the common shares of the Company in the event of a liquidation, dissolution or winding up. We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the "Risk Factors" section of our MD&A for the year ended December 31, 2023 and the Company's Annual Information Form, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language. 1) EBITDA and adjusted EBITDA are non-IFRS financial measures. These non-IFRS measures are not recognized measures under IFRS and do not have a standardized meaning prescribed by IFRS and are unlikely to be comparable to similar measures presented by other companies. Management uses non-IFRS measures such as Earnings Before Interest, Taxes, Depreciation and Amortization ("EBITDA") and Adjusted EBITDA to provide investors with supplemental measures of the Company's operating performance and thus highlight trends in the Company's core business that may not otherwise be apparent when relying solely on IFRS financial measures. The Company defines Adjusted EBITDA as earnings before interest expense, income taxes, depreciation of property and equipment, amortization of intangible assets, non-cash share-based compensation, changes in fair value of derivative financial instruments, provision for legal settlement, loss on disposal of assets and loss on extinguishment of lease, impairment of intangible assets, acquisition costs, restructuring costs and unrealized foreign exchange gains and losses. 2) IQVIA market data as at June 30, 2024. The following is a summary of how EBITDA and Adjusted EBITDA are calculated: Consolidated statements of income and comprehensive income Consolidated statements of financial position SOURCE Cipher Pharmaceuticals Inc.

AcquisitionPhase 3Financial StatementExecutive Change

26 Oct 2023

·www.prnewswire.com

PARAPRO'S THOUGHT LEADER AI: WHERE ARTIFICIAL INTELLIGENCE MEETS SCABIES EXPERTISE

AI-driven Virtual Consultation Platform with Leading Medical Experts CARMEL, Ind., Oct. 26, 2023 /PRNewswire/ -- ParaPRO, a leading specialty pharmaceutical company specializing in innovative treatments for human ectoparasites, has unveiled Thought Leader AI. This cutting-edge decision support tool, developed in collaboration with the Institute for Creative Technologies (ICT) at the University of Southern California, enables healthcare practitioners to conduct lifelike consultations with top scabies specialists. From diagnosis to treatment, Thought Leader AI aims to support clinical decision-making and foster a virtual exchange of expert insights. Healthcare providers can visit to experience Thought Leader AI in action. Non-healthcare providers can contact [email protected] to receive instructions on how to access the platform. Continue Reading ParaPRO's Thought Leader AI: Where Artificial Intelligence Meets Scabies Expertise. This transformative platform utilizes advanced AI-based natural language processing to distill precise responses from extensive curated video footage featuring three disease-state experts. It offers real-time, evidence-based consultations for diagnosis, treatment planning, and patient management. By allowing healthcare practitioners to tap into novel perspectives and expert insights, Thought Leader AI establishes a vibrant virtual forum for best practices. The highly respected experts featured on the platform are: Dr. Theodore Rosen, MD, FAAD, Professor of Dermatology at Baylor College of Medicine; Chief of Dermatology Services at Michael E. DeBakey Veterans Affairs Medical Center Dr. Anthony J. Mancini, MD, FAAP, FAAD, Division Head & Associate Fellowship Program Director, Dermatology, Ann & Robert H. Lurie Children's Hospital of Chicago; Professor of Pediatrics and Dermatology, Northwestern Feinberg School of Medicine. Dr. Christopher Belcher, MD, FAAP, Director of Pediatric Infectious Disease, Payton Manning Children's Hospital, St. Vincent/Ascension. "We are excited to broaden access to Thought Leader AI so that all healthcare practitioners can easily access this transformative decision support tool," said Bill Culpepper III, President of ParaPRO. "This new technology allows clinicians, many of whom don't often see scabies in their practices, to engage in "live" consults with well-known medical specialists on scabies anytime, anywhere. It's akin to having the world's leading experts at your side in real-time. Thought Leader AI also informs clinicians about available treatment options, including the first and only FDA-approved 'complete cure' for scabies." Added Dr. Rosen, "This platform has the potential to revolutionize how medical professionals approach complex cases and collaborate to provide the highest quality care. With Thought Leader AI, healthcare professionals can make more informed decisions, collaborate seamlessly, and deliver expected outcomes." With scabies affecting nearly 1 million Americans yearly1, accurate diagnosis and effective treatment remain paramount. Thought Leader AI addresses these challenges head-on, allowing practitioners to seek real-time expert advice, gain invaluable clinical insights, and explore best practices. About Scabies Scabies is a pervasive global health challenge. Affecting a diverse demographic, it thrives and spreads in crowded environments due to direct, prolonged skin-to-skin transmission.2 Caused by an infestation of the skin by the human itch mite, Sarcoptes scabiei var. hominis, symptoms primarily include intense itching and a distinct skin rash. About Natroba Natroba (spinosad) Topical Suspension, 0.9% is an FDA-approved, targeted topical prescription therapy with multi-ectoparasitic indications. Natroba is indicated for the topical treatment of scabies infestations in adult and pediatric patients four (4) years of age and older and is the only FDA-approved, targeted topical prescription therapy that meets the latest FDA criteria for effectiveness and safety in treating scabies infestations.3-6 Natroba is dosed as a single, full-body application. Click here for a video on how to properly apply Natroba. IMPORTANT SAFETY INFORMATION Indication Natroba™ Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients six (6) months of age and older. Adjunctive Measures Natroba™ Topical Suspension should be used in the context of an overall lice management program: Wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels Wash personal care items such as combs, brushes, and hair clips in hot water A fine-tooth comb or special nit comb may be used to remove dead lice and nits. Important Safety Information Natroba™ Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Intravenous administration of benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. About ParaPRO ParaPRO LLC. is a specialty pharmaceutical company focused on innovating anti-parasitic formulations that minimize the disruption and economic burden on patients and families and providing support for the broader professional community with the most current insights, tools and resources that educate and inform. In 2021, the company introduced the first product (new drug application) for scabies to be approved by the U.S. Food and Drug Administration (FDA) in more than 30 years and the only targeted topical therapy that meets the FDA's new criteria for a "complete cure".7,8 For more information, visit References IQVIA March 2019-March 2021. Centers for Disease Control and Prevention. Parasites. . Accessed, 9/26/22. Natroba Prescribing Information. Data on file, ParaPRO, LLC. Summary of NDA approvals & receipts, 1938 to the present. US FDA website. . Accessed January 19, 2021. LaMaina J. Can the record-breaking number of FDA new drug approvals continue? Forbes website. record-breaking-number-of-fda-new-drug-approvals-continue/?sh=260bdf15aa83. Published January 9, 2019. Accessed January 19, 2021. U.S. FDA (n.d.). Orange Book: Approved Drug products with Therapeutic Equivalence Evaluations. . Accessed, 9/26/22. Data on file, ParaPRO, LLC SOURCE ParaPRO, LLC

Drug Approval

100 Deals associated with Spinosad

External Link

KEGG	Wiki	ATC	Drug Bank
D09384	Spinosad	P03	DB08823

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Scabies	US	ParaPRO LLC	28 Apr 2021
Lice Infestations	US	ParaPRO LLC	18 Jan 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pediculus capitis infestation	Phase 1	US	ParaPRO LLC	01 Dec 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02485704 (CTgov)	Phase 3	Scabies	280	spinosad topical suspension, 0.9% (Natroba (Spinosad))	ieedkywxzu(vuqmymhwyf) = badjbijrms coauflhuct (yblepiznnf, mfnhhhepcs - fadugbyavh) View more	-	16 Jan 2019
				Placebo (Placebo)	ieedkywxzu(vuqmymhwyf) = mjemzbkhyd coauflhuct (yblepiznnf, vmduxyuieo - cxzxfufghv) View more
NCT01660321 (CTgov)	Phase 4	Lice Infestations	26	spinosad	jqnvwdqinh(dahnbxsnqi) = lhadipfjbu hrhkltgoaj (wxrdbzerze, imzanvtowk - nmyecsiymo) View more	-	19 Nov 2012
NCT00545168 (CTgov)	Phase 3	Lice Infestations	480	Permethrin 1% (C - NIX)	merowrxtya(mwbawlcthb) = agjutjwsry vplvrpfpey (djkslftime, tseqtpravs - hzcsmpldvs) View more	-	11 Oct 2012
				Spinosad (A - NatrOVA 1% - no Nit Combing)	merowrxtya(mwbawlcthb) = rrsrazalup vplvrpfpey (djkslftime, iwaqxqqlzw - yvrtpwrndw) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis