Evaluation of a Novel Intranasal Spray Formulation of Replax for the Treatment of Acute Migraine Attacks

Main Article Content

Zainab Rahi Hanthal
Mahdi abd zair

Abstract

A strong, repeated headache attack that is frequently accompanied by nausea, vomiting, and sensitivity to light and sound is the hallmark of the neurological condition known as migraine. Despite the availability of several treatments, there is still a demand for a quick and efficient way to reduce migraine symptoms. This study examines the creation and assessment of a brand-new intranasal spray version of the well-known migraine therapy Replax. This trial evaluates a brand-new intranasal Replax formulation for the treatment of acute migraines. A promising potency is shown by the pharmacokinetic studies, which show a rapid start of action with a Tmax of 15 minutes and a significant Cmax of about 1000 ng/mL. 40% high bioavailability confirms effective medication uptake. The 10 mg dosage is recommended by dose-response analysis as having a 9.5 effectiveness rating and a 5.0 tolerability rating. Positive toxicological findings back up safety. These preclinical discoveries must be confirmed in clinical studies in order to potentially improve acute migraine therapy choices.

Article Details

How to Cite
Zainab Rahi Hanthal, & Mahdi abd zair. (2024). Evaluation of a Novel Intranasal Spray Formulation of Replax for the Treatment of Acute Migraine Attacks. International Journal of Pharmaceutical and Bio Medical Science, 4(6), 495–501. https://doi.org/10.47191/ijpbms/v4-i6-03
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Articles

References

I. Dodick DW. Migraine. Lancet. 2018 Mar 31;391(10127):1315-1330. doi: 10.1016/S0140-6736(18)30478-1. Epub 2018 Mar 6. PMID: 29523342.

II. Pescador Ruschel MA, De Jesus O. Migraine Headache. [Updated 2023 Feb 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560787/

III. Pescador Ruschel MA, De Jesus O. Migraine Headache. 2023 Feb 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan–. PMID: 32809622

IV. Eigenbrodt AK, Ashina H. Diagnosis and management of migraine in ten steps. Nat Rev Neurol. 2021 Aug;17(8):501-514. doi: 10.1038/s41582-021-00509-5. Epub 2021 Jun 18. PMID: 34145431; PMCID: PMC8321897.

V. Allais G, Chiarle G, Sinigaglia S, Airola G, Schiapparelli P, Benedetto C. Gender-related differences in migraine. Neurol Sci. 2020 Dec;41(Suppl 2):429-436. doi: 10.1007/s10072-020-04643-8. PMID: 32845494; PMCID: PMC7704513.

VI. Lewis DW. Migraine and migraine variants in childhood and adolescence. Semin Pediatr Neurol. 1995 Jun;2(2):127-43. doi: 10.1016/s1071-9091(05)80023-3. PMID: 9422240.

VII. VanderPluym JH, Halker Singh RB, Urtecho M, Morrow AS, Nayfeh T, Torres Roldan VD, Farah MH, Hasan B, Saadi S, Shah S, Abd-Rabu R, Daraz L, Prokop LJ, Murad MH, Wang Z. Acute Treatments for Episodic Migraine in Adults: A Systematic Review and Meta-analysis. JAMA. 2021 Jun 15;325(23):2357-2369. doi: 10.1001/jama.2021.7939. PMID: 34128998; PMCID: PMC8207243.

VIII. Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014;34(2):114-125. doi:

1177/0333102413500727

IX. Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. PMID: 35281991; PMCID: PMC8904749.

X. Kronzer VL, Bridges SL Jr, Davis JM 3rd. Why women have more autoimmune diseases than men: An evolutionary perspective. Evol Appl. 2020 Dec 1;14(3):629-633. doi: 10.1111/eva.13167. PMID: 33767739; PMCID: PMC7980266.

XI. Burch R. Preventive Migraine Treatment. Continuum (Minneap Minn). 2021 Jun 1;27(3):613-632. doi: 10.1212/CON.0000000000000957. Erratum in: Continuum (Minneap Minn). 2021 Oct 1;27(5):1494-1495. PMID: 34048395.

XII. Ong JJY, De Felice M. Migraine Treatment: Current Acute Medications and Their Potential Mechanisms of Action. Neurotherapeutics. 2018 Apr;15(2):274-290. doi: 10.1007/s13311-017-0592-1. Erratum in: Neurotherapeutics. 2018 Jan 8;: PMID: 29235068; PMCID: PMC5935632.

XIII. Aguilar-Shea AL, Membrilla Md JA, Diaz-de-Teran J. Migraine review for general practice. Aten Primaria. 2022 Feb;54(2):102208. doi: 10.1016/j.aprim.2021.102208. Epub 2021 Nov 16. PMID: 34798397; PMCID: PMC8605054.

XIV. Savjani KT, Gajjar AK, Savjani JK. Drug solubility: importance and enhancement techniques. ISRN Pharm. 2012;2012:195727. doi: 10.5402/2012/195727. Epub 2012 Jul 5. PMID: 22830056; PMCID: PMC3399483.

XV. Tonog P, Lakhkar AD. Normal Saline. [Updated 2022 Oct 16]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK545210/

XVI. Rao VA, Kim JJ, Patel DS, Rains K, Estoll CR. A Comprehensive Scientific Survey of Excipients Used in Currently Marketed, Therapeutic Biological Drug Products. Pharm Res. 2020 Sep 24;37(10):200. doi: 10.1007/s11095-020-02919-4. Erratum in: Pharm Res. 2022 Apr;39(4):825. PMID: 32968854; PMCID: PMC9010397.

XVII. Hughes, O.B., Maderal, A.D. & Tosti, A. Preservative Sensitization—Safety With and Safety Without. Curr Treat Options Allergy 3, 345–358 (2016). https://doi.org/10.1007/s40521-016-0102-4

XVIII. Halla N, Fernandes IP, Heleno SA, Costa P, Boucherit-Otmani Z, Boucherit K, Rodrigues AE, Ferreira ICFR, Barreiro MF. Cosmetics Preservation: A Review on Present Strategies. Molecules. 2018 Jun 28;23(7):1571. doi: 10.3390/molecules23071571. PMID: 29958439; PMCID: PMC6099538.

XIX. Vadodaria, S.S., English, R.J. Aqueous solutions of HEC and hmHEC: effects of molecular mass versus hydrophobic associations on hydrodynamic and thermodynamic parameters. Cellulose 23, 1107–1121 (2016). https://doi.org/10.1007/s10570-016-0861-x

XX. Tuomela A, Hirvonen J, Peltonen L. Stabilizing Agents for Drug Nanocrystals: Effect on Bioavailability. Pharmaceutics. 2016 May 20;8(2):16. doi: 10.3390/pharmaceutics8020016. PMID: 27213435; PMCID: PMC4932479.