Nausea Archives - MPR

Acupuncture, Doxylamine-Pyridoxine Ease Nausea, Vomiting in Pregnancy

Haymarket Media — Wed, 21 Jun 2023 13:00:00 +0000

HealthDay News — For women with moderate-to-severe nausea and vomiting of pregnancy (NVP), both acupuncture and doxylamine-pyridoxine are efficacious, and the combination may yield a larger benefit than either treatment alone, according to a study published online June 20 in the Annals of Internal Medicine.

Xiao-Ke Wu, MD, PhD, from the Heilongjiang University of Chinese Medicine in Harbin, and colleagues examined the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in 352 women in early pregnancy with moderate-to-severe NVP. Participants received 30 minutes of daily active or sham acupuncture and 14 days of doxylamine-pyridoxine or placebo.

The researchers observed no significant interaction between the interventions. A larger reduction in the Pregnancy-Unique Quantification of Emesis score was seen over the treatment course for acupuncture, doxylamine-pyridoxine, and the combination of both compared with their respective control groups (mean differences, −0.7, −1.0, and −1.6, respectively). The risk for births with children who were small for gestational age was higher with doxylamine-pyridoxine vs placebo.

“The combination of both treatments showed numerically larger and potentially more clinically meaningful benefit than either treatment alone,” the authors write. “This finding is especially significant because there is a pressing need to establish a pregnancy-safe treatment regimen and an integrative guideline for managing severe NVP.”

One author disclosed ties to industry.

AKYNZEO

Haymarket Media — Thu, 22 Jul 2021 11:35:11 +0000

Netupitant, palonosetron (as HCl); 300mg/0.5mg; hard gel caps.

AKYNZEO FOR INJECTION

Haymarket Media — Thu, 22 Jul 2021 11:46:32 +0000

Fosnetupitant, palonosetron; 235mg/0.25mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.

AKYNZEO INJECTION

Haymarket Media — Thu, 22 Jul 2021 11:54:18 +0000

Fosnetupitant, palonosetron; 235mg/0.25mg/20mL; per vial; soln for IV infusion after dilution; preservative-free.

Antiemetic Treatments

Haymarket Media — Tue, 10 Mar 2015 18:30:00 +0000

Antiemetic Treatments

ANTIEMETIC TREATMENTS
Generic	Brand		Strength	Form	Usual Dose
ANTICHOLINERGICS
scopolamine	Transderm SCOP	Rx	1.5mg (delivers 1mg per 72hrs)	trans– dermal patch	Adults: Motion sickness: 1 patch ≥4hrs before required effect; remove after 72hrs. Apply a new patch if therapy is required >3 days. PONV (for surgeries except cesarean): 1 patch evening before surgery; remove 24hrs after surgery. Children: Not established.
ANTIHISTAMINES
dimenhy– drinate	Dramamine	OTC	50mg	tabs, chew tabs	Adults: Motion sickness: ≥12yrs: 50–100mg every 4–6hrs, start ½–1hr before travel; max 400mg/day. Children: <2yrs: Not recommended. Motion sickness: start ½–1hr before travel; may repeat every 6–8hrs. 2–6yrs: 12.5–25mg; max 75mg/day. 6–11yrs: 25–50mg; max 150mg/day.
diphen– hydramine	—	Rx	50mg/mL	IV or IM inj	Adults: 10−50mg IV or deep IM; max 400mg/day. Children: 5mg/kg/day in 4 divided doses; max 300mg/day.
meclizine	—	Rx	12.5mg, 25mg	tabs	Adults: Motion sickness: 25–50mg 1hr before travel; repeat every 24hrs as needed. Vertigo: 25–100mg/day in divided doses. Children: Not established.
meclizine	Zentrip	OTC	25mg	orally-disinte– grating thin strips	Adults: 1 or 2 strips once daily 1hr before travel. Children: Not recommended.
CANNABINOIDS
dronabinol	Marinol	CIII	2.5mg, 5mg, 10mg	caps	Adults: Initially 5mg/m² 1–3hrs before chemo, then every 2–4hrs after chemo; max 4–6 doses/day. May increase if needed by increments of 2.5mg/m²; max 15mg/m² per dose. May decrease to 2.5mg once daily before chemo to reduce adverse events. Elderly: initially 2.5mg/m² once daily. Children: Not established.
dronabinol	Syndros	CII	5mg/mL	oral soln	Adults: Give 1st dose ≥30mins before eating. Initially 4.2mg/m² 1–3hrs before chemo then every 2–4hrs after chemo; total 4–6 doses/day. Elderly: 2.1mg/m² once daily 1–3hrs before chemo. May increase in increments of 2.1mg/m²; max 12.6mg/m² per dose for 4–6 doses/day. May reduce to 2.1mg once daily 1–3hrs before chemo if needed. Children: Not established.
nabilone	Cesamet	CII	1mg	caps	≥18yrs: 1−2mg twice daily; max 6mg/day in 3 divided doses. Start 1−3 hrs before chemo. <18yrs: Not recommended.
DOPAMINE-2 RECEPTOR ANTAGONIST
amisulpride	Barhemsys	Rx	2.5mg/mL	soln for IV infusion	Adults: Infuse over 1–2mins. PONV (Prevention): 5mg IV once at the time of induction of anesthesia; (Treatment): 10mg IV once in the event of nausea and/or vomiting after a surgical procedure. Children: Not established.
5-HT₃ RECEPTOR ANTAGONISTS
dolasetron	Anzemet	Rx	50mg, 100mg	tabs	Adults: ≥16yrs: 100mg within 1hr before chemo. Children: <2yrs: Not established. 2–16yrs: 1.8mg/kg (max 100mg) within 1hr before chemo.
granisetron	—	Rx	1mg	tabs	Adults: 2mg up to 1hr before chemo; or 1mg up to 1hr before, then 1mg 12hrs later. Radiation: 2mg within 1hr.
	—	Rx	1mg/mL	IV inj	Adults and Children: Chemotherapy: ≥2yrs: 10mcg/kg within 30mins of initiating chemo. PONV (adults): infuse 1mg undiluted IV over 30secs.
	Sancuso	Rx	3.1mg/ day	trans– dermal patch	≥18yrs: 1 patch 24−48hrs before chemo, remove at least 24hrs after completion; max 7 days. <18yrs: Not recommended.
	Sustol	Rx	10mg/ 0.4mL	ext-rel SC inj	≥18yrs: Give as SC inj over 20–30secs with IV dexamethasone ≥30mins before chemotherapy. 10mg on Day 1 of chemotherapy; give no sooner than once every 7 days. MEC: use IV dexamethasone 8mg on Day 1. AC: use IV dexamethasone 20mg on Day 1, then 8mg orally twice daily on Days 2–4. <18yrs: Not established.
ondansetron	—	Rx	2mg/mL	IV or IM inj	Adults and Children: Chemotherapy: <6mos: see full labeling. ≥6mos: 0.15mg/kg (max 16mg/dose) IV every 4hrs for 3 doses 30mins before chemo. Post-op: Give as IV inj before anesthesia or shortly post-op. <1 month: see full labeling. 1 month–12yrs (<40kg): 0.1mg/kg; (≥40kg): 4mg. >12yrs: 4mg.
	—	Rx	4mg, 8mg	ODT	Adults: Highly emetogenic: 24mg 30min before chemo. Moderately emetogenic: 8mg every 8hrs for 2 doses starting 30min before chemo, then 8mg every 12hrs for 1−2 days after. Post‑op: 16mg 1hr before anesthesia induction. TBI, single or daily fractionated radiotherapy to abdomen: See drug monographs. Children: Highly emetogenic, radiotherapy, post-op prophylaxis or <4yrs: Not established. Moderately emetogenic: 4–11yrs: 4mg every 4hrs for 3 doses 30mins before chemo, then 4mg every 8hrs for 1–2 days after.
			4mg/5mL	oral soln
			4mg, 8mg	tabs
palonosetron	—	Rx	0.075mg/ 1.5mL 0.25mg/ 5mL	IV inj	Adults: ≥17yrs: Chemotherapy: 0.25mg IV 30mins before chemo. Post-op: 0.075mg IV before anesthesia. Children: <1 month: Not established. Chemotherapy: 1 month–<17yrs: 0.02mg/kg IV 30mins before chemo; max 1.5mg/dose.
PHENOTHIAZINES
chlorpro– mazine	—	Rx	10mg, 25mg, 50mg, 100mg, 200mg	tabs	Adults: Tabs: 10–25mg every 4–6hrs. IM: 25–50mg every 3–4hrs. Children: <6mos: Not recommended. ≥6mos: tabs: 0.25mg/lb every 4–6hrs. IM: 0.25mg/lb every 6–8hrs. <5yrs or <50lbs: max 40mg/day; ≥5yrs or 50–100lbs: usual max 75mg/day.
chlorpro– mazine	—	Rx	25mg/mL	IV or IM inj
prochlor– perazine	—	Rx	5mg, 10mg	tabs	Adults: Oral: 5−10mg 3−4 times daily; max 40mg/day. Rectal: 25mg twice daily. Children: <2yrs or <20lbs: Contraindicated. Oral: 20–29lbs: 2.5mg once or twice daily; max 7.5mg/day. 30–39lbs: 2.5mg 2–3 times daily; max 10mg/day. 40–85lbs: 2.5mg 3 times daily or 5mg twice daily; max 15mg/day.
prochlor– perazine	—	Rx	25mg	supps
promethazine	—	Rx	12.5mg, 25mg, 50mg	tabs	Adults: Motion sickness: 25mg 30−60min before travel. Maintenance: 25mg twice daily. Perioperative N/V: 25mg; may give additional doses of 12.5−25mg every 4−6hrs. Children: <2yrs: Contraindicated. Motion sickness: ≥2yrs: 12.5–25mg twice daily. Perioperative N/V: 0.5mg/lb or 25mg; may give additional doses of 12.5–25mg or 0.5mg/lb every 4–6hrs.
promethazine	—	Rx	12.5mg, 25mg, 50mg	supps
SUBSTITUTED BENZAMIDES
metoclo– pramide	—	Rx	5mg	ODT	Adults: Diabetic gastroparesis: 10mg 4 times daily 30min before meals and at bedtime for 2−8wks. Children: Not recommended.
	Reglan	Rx	5mg, 10mg	tabs
	—	Rx	5mg/mL	IV or IM inj	Adults: Diabetic gastroparesis (severe): give 10mg by slow IV inj over a 1–2min period, up to 10 days; initiate oral form when feasible. Chemotherapy induced: give by slow IV infusion (≥15mins) 30mins before chemotherapy and repeat every 2hrs for 2 doses, then every 3hrs for 3 doses. Highly emetogenic: 2mg/kg for initial 2 doses; less emetogenic: 1mg/kg per dose. PONV: usually 10mg IM inj near the end of surgery; 20mg doses may be used. Children: Not recommended.
trimetho– benzamide	—	Rx	300mg	caps	Adults: 200mg (IM) or 300mg (oral) 3−4 times daily. Children: Not recommended.
trimetho– benzamide	Tigan	Rx	100mg/ mL	IM inj
SUBSTANCE P/NEUROKININ 1 RECEPTOR ANTAGONIST
aprepitant	Aponvie	Rx	32mg/ 4.4mL	emulsion for IV inj	Adults: PONV: Give prior to induction of anesthesia. 32mg IV over 30secs. Children: Not established.
	Cinvanti	Rx	130mg/ 18mL	emulsion for IV inj or infusion after dilution	Adults: Give with dexamethasone and 5-HT₃ antagonist (see full labeling) approx. 30mins before chemo. Give by IV inj over 2mins (do not dilute) or by IV infusion over 30mins. MEC (3-day regimen): 100mg IV on Day 1, then oral aprepitant 80mg on Days 2 and 3. Moderately to highly emetogenic (single-dose regimen): 130mg IV on Day 1. Children: Not established.
	Emend	Rx	80mg, 125mg	caps	Adults: Chemotherapy induced: ≥12yrs: Give with corticosteroid and 5-HT₃ antagonist 1hr before chemo. Day 1: 125mg. Days 2 and 3: 80mg; if no chemotherapy given, administer caps in the AM. Children: Chemotherapy induced: <12yrs: use oral susp.
	Emend Oral Suspension	Rx	125mg	pwd for oral susp	Adults and Children: <6mos or <6kg: Not recommended. 6mos–<12yrs or unable to swallow: Give with corticosteroid and 5-HT₃ antagonist (see full labeling) 1hr before chemo. Day 1: 3mg/kg (max 125mg). Days 2 and 3: 2mg/kg (max 80mg); if no chemotherapy given, administer susp in the AM.
fosaprepitant dimeglumine	Emend Injection	Rx	150mg/ vial	pwd for IV infusion after reconstitution and dilution	Adults: ≥18yrs: Give with corticosteroid and 5-HT₃ antagonist (see full labeling) 30mins before chemo. 150mg IV over 20–30mins on Day 1. Children: <6mos or <6kg: Not recommended. Give with 5-HT3 antagonist with or without corticosteroid (see full labeling) 30mins before chemo. Single-day chemo: 6mos–<2yrs: 5mg/kg (max 150mg) IV once over 60mins; 2yrs–<12yrs: 4mg/kg (max 150mg) IV once over 60mins; 12–17yrs: 150mg IV once over 30mins. Multi-day chemo: 6mos–<12yrs: 3mg/kg (max 115mg) IV once over 60mins on Day 1; then 2mg/kg (max 80mg) IV once over 60mins or may give 2mg/kg oral susp or caps (if ≥40kg & able to swallow caps) on Days 2 and 3. 12–17yrs: 115mg IV once over 30mins on Day 1; then 80mg IV once over 30mins or may give 80mg oral caps or susp (if unable to swallow caps) on Days 2 and 3.
rolapitant	Varubi	Rx	90mg	tabs	≥18yrs: Give before each cycle, at no less than 2wk intervals. Highly emetogenic cisplatin-based chemotherapy: 180mg within 2hrs before chemo with dexamethasone 20mg given 30mins before chemo and a 5-HT3 receptor antagonist (see drug’s full labeling for dosing) on Day 1, then dexamethasone 8mg twice daily on Days 2–4. MEC and AC regimens: 180mg within 2hrs before chemo with dexamethasone 20mg given 30mins before chemo on Day 1 and a 5-HT3 receptor antagonist (see drug’s full labeling for dosing) on Days 1–4. <18yrs: Not established.
SUBSTANCE P/NEUROKININ 1 RECEPTOR ANTAGONIST + 5-HT₃ RECEPTOR ANTAGONIST
netupitant/ palonosetron	Akynzeo	Rx	Rx	300mg/ 0.5mg	caps	≥18yrs: Highly emetogenic: 1 cap 1hr before chemo with dexamethasone 12mg PO given 30mins before chemo on Day 1, then 8mg PO once daily on Days 2–4. AC or non-highly emetogenic: 1 cap 1hr before chemo with dexamethasone 12mg PO given 30mins before chemo on Day 1. <18yrs: Not established.
		235mg/ 0.25mg/ 20mL		soln for IV infusion after dilution	≥18yrs: Highly emetogenic: 1 vial 30mins before chemo with dexamethasone 12mg PO given 30mins before chemo on Day 1, then 8mg PO once daily on Days 2–4. <18yrs: Not established.
		235mg/ 0.25mg per vial		pwd for IV infusion after reconstitution and dilution
NOTES
Key: AC = anthracycline and cyclophosphamide combination; MEC = moderately emetogenic chemotherapy; TBI = total body irradiation; ODT = orally disintegrating tab; PONV = postoperative nausea and vomiting Patients’ individual needs may vary. Adjust dose based on clinical effect. Not an inclusive list of medications, official indications, and/or doses. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. (Rev. 9/2023)

ANZEMET

Haymarket Media — Tue, 01 Aug 2023 15:14:23 +0000

Dolasetron mesylate 50mg, 100mg; tabs.

APONVIE

Haymarket Media — Thu, 20 Jul 2023 13:38:57 +0000

Aprepitant 32mg/4.4mL (7.2mg/mL); emulsion for IV inj; contains egg lecithin, ethanol, soybean oil, sucrose.

Aponvie Now Available for Postop Nausea and Vomiting

Diana Ernst, RPh — Mon, 06 Mar 2023 21:00:00 +0000

Aponvie (aprepitant) has been made available by Heron Therapeutics for the prevention of postoperative nausea and vomiting in adults.

Aponvie is an injectable emulsion formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. The formulation is identical to Heron’s approved drug product Cinvanti^®, which is indicated for chemotherapy-induced nausea and vomiting.

The safety and efficacy of Aponvie were established based on adequate and well-controlled studies of a single-dose of oral aprepitant in adults. Additionally, a single 32mg dose of Aponvie was found to be bioequivalent to oral aprepitant 40mg in a phase 1 study.

Aponvie is supplied in a single-dose vial containing 32mg of aprepitant.

References

B-NATAL LOZENGE

Haymarket Media — Thu, 22 Jul 2021 10:35:30 +0000

Pyridoxine 25mg; lozenge; green apple flavor.

B-NATAL THERAPOPS

Haymarket Media — Thu, 22 Jul 2021 10:35:32 +0000

Pyridoxine 25mg; lollipop; cherry flavor.

BARHEMSYS

Haymarket Media — Thu, 22 Jul 2021 11:54:26 +0000

Amisulpride 2.5mg/mL; soln for IV infusion.

BONJESTA

Haymarket Media — Thu, 22 Jul 2021 11:46:45 +0000

Doxylamine succinate 20mg, pyridoxine HCl 20mg; ext-rel tabs.

CESAMET

Haymarket Media — Thu, 22 Jul 2021 10:35:35 +0000

Nabilone 1mg; caps.

Chemotherapy-Induced Nausea and Vomiting Prophylaxis

Kim Daigneau — Fri, 15 May 2020 16:00:10 +0000

Chemotherapy-Induced Nausea and Vomiting Prophylaxis

CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING PROPHYLAXIS
The recommended approach for the prevention and management of chemotherapy-induced nausea and vomiting (CINV) varies by the emetic risk of the treatment regimen. Adherence to antiemetic guidelines has resulted in improved control of nausea and vomiting, and improved adherence to chemotherapy regimen. The ASCO guideline provides updated recommendations for the prevention and management of nausea and vomiting due to antineoplastic agents for cancer.
ANTIEMETIC REGIMENS
Emetic risk category^1,2	Drug regimen
High emetic risk	NK₁ receptor antagonist + 5-HT₃ receptor antagonist + dexamethasone + olanzapine
Moderate emetic risk³	5-HT₃ receptor antagonist + dexamethasone
Low emetic risk	5-HT₃ receptor antagonist OR dexamethasone
Minimal emetic risk	No routine antiemetic prophylaxis
Breakthrough / Refractory	Add to standard antiemetic regimen: olanzapine or drug of a different class or benzodiazepine or dopamine receptor antagonist or cannabinoids
ANTIEMETIC DOSING
Drug	Day 1⁴	Day 2	Day 3	Day 4
HIGH RISK
NK₁ receptor antagonist³
Aprepitant OR	125mg PO or 130mg IV	80mg PO (if oral aprepitant on Day 1)	80mg PO (if oral aprepitant on Day 1)
FosaprepitantOR	150mg IV
Rolapitant OR	180mg PO
Fosnetupitant-palonosetron⁵	235mg/0.25mg IV
Netupitant-palonosetron⁵	300mg/0.5mg PO
5-HT₃ receptor antagonist⁵
Granisetron OR	2mg PO OR 1mg or 0.01mg/kg IV OR 1 patch OR 10mg SC
Ondansetron OR	24mg PO (tabs or soluble film) OR 8mg or 0.15mg/kg IV
Palonosetron OR	0.25mg IV
Dolasetron	100mg PO
Corticosteroid
Dexamethasone⁶	12mg PO or IV⁷	8mg PO or IV^7,8,9	8mg PO or IV^7,8,9	8mg PO or IV^7,8,9
Atypical Antipsychotic
Olanzapine	10mg or 5mg PO	10mg or 5mg PO⁸	10mg or 5mg PO⁸	10mg or 5mg PO⁸
Moderate risk³
5-HT₃ receptor antagonist
Granisetron OR	2mg PO OR 1mg or 0.01mg/kg IV OR 1 patch OR 10mg SC
Ondansetron OR	8mg PO twice daily OR 8mg soluble film twice daily OR 8mg or 0.15mg/kg IV
Palonosetron OR	0.50mg PO OR 0.25mg IV
Dolasetron	100mg PO
Corticosteroid
Dexamethasone³	8mg PO or IV	8mg PO or IV¹⁰	8mg PO or IV¹⁰
LOW RISK
5-HT₃ receptor antagonist
Granisetron OR	2mg PO OR 1mg or 0.01mg/kg IV OR 1 patch OR 10mg SC
Ondansetron OR	8mg PO (tab or soluble film) OR 8mg IV
Palonosetron OR	0.25mg IV
Dolasetron	100mg PO
Corticosteroid
Dexamethasone	8mg PO or IV
NOTES
Key: 5HT₃ = 5-hydroxytryptamine-3 (serotonin); AUC = area under the curve; CINV = chemotherapy induced nausea and vomiting; IV = intravenous; NK₁ = neurokinin 1; PO = oral; SC = subcutaneous ¹ For emetic risk category of chemotherapeutic agents, see “Emetogenic Potential of Antineoplastic Agent” chart. ² Adults treated with antineoplastic combinations should receive the antiemetic regimen appropriate for the component antineoplastic agent of greatest emetic risk. ³ For adults treated with carboplatin AUC ≥4mg/mL (emetic risk is at the higher end of the moderate-emetic risk category), add NK₁ receptor antagonist for a 3-drug regimen. Dexamethasone dosing is Day 1 only: 20mg with rolapitant, and 12mg with aprepitant, fosaprepitant, or netupitant-palonosetron. ⁴ Give antiemetic regimen on the day of chemotherapy (single-day) before the dose of the antineoplastic agent. For multi-day chemotherapy, first determine the emetic risk of the agent(s) included in the regimen. Patients should receive the agent of the highest therapeutic index daily during chemotherapy and for 2 days thereafter. Granisetron transdermal patch or granisetron ext-rel inj, which deliver therapy over multiple days rather than a daily 5-HT₃ receptor antagonist, can be given. ⁵ If netupitant-palonosetron or fosnetupitant-palonosetron is used, no additional 5-HT₃ receptor antagonist is needed. ⁶ Dexamethasone dosing is for patients receiving the recommended 4-drug regimen for high-emetic risk. If NK₁ receptor antagonist was omitted, the dexamethasone dose should be adjusted to 20mg on Day 1 and 16mg on Days 2–4. ⁷ If rolapitant is used, give with dexamethasone 20mg PO or IV on Day 1, and 8mg PO or IV twice daily on Days 2–4. ⁸ For cisplatin and other high-emetic-risk single agents, dexamethasone and olanzapine should be continued on Days 2–4. For anthracycline + cyclophosphamide regimens, only continue olanzapine on Days 2–4. ⁹ If fosaprepitant is used, give with dexamethasone 8mg PO or IV on Day 2, and 8mg PO or IV twice daily on Days 3–4. ¹⁰ For moderate-emetic risk agents that are known to cause delayed nausea & vomiting (eg, cyclophosphamide, doxorubicin, oxaliplatin), may continue dexamethasone on Days 2–3.
REFERENCES
Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO Guideline Update. J Clin Oncol. 2020;38(24):2782-2797. doi:10.1200/JCO.20.01296. (Rev 5/2023)

Chlorpromazine

Haymarket Media — Fri, 08 Oct 2021 16:30:48 +0000

Chlorpromazine HCl 10mg, 25mg, 50mg, 100mg, 200mg; tabs; contains parabens.

Chlorpromazine Injection

Haymarket Media — Fri, 08 Oct 2021 16:30:07 +0000

Chlorpromazine HCl 25mg/mL; for IV inj after dilution or IM inj; contains sulfites; multidose vials contain benzyl alcohol.

CINVANTI

Haymarket Media — Thu, 22 Jul 2021 11:46:56 +0000

Aprepitant 130mg/18mL; emulsion for IV inj or infusion after dilution; contains egg lecithin, ethanol.

Defender Seeks Approval of Intranasal Scopolamine for Motion Sickness Prevention

Steve Duffy — Fri, 28 Jul 2023 13:00:00 +0000

The New Drug Application (NDA) for an intranasally administered scopolamine gel (DPI-386 nasal gel) has been submitted to the Food and Drug Administration (FDA) as a potential preventive therapy for motion sickness.

The application includes data from 5 clinical trials including results from a phase 3 double-blind, placebo-controlled study (ClinicalTrials.gov Identifier: NCT05548270) that included approximately 500 individuals 18 years of age and older who were exposed to motion on an ocean voyage.

Findings showed the proportion of patients who did not report vomiting and did not request rescue medication (primary endpoint) was significantly greater in the intranasal scopolamine arm compared with the placebo arm (P <.0001). Additionally, intranasal scopolamine was found to be significantly more effective at reducing moderate to severe nausea than placebo (P <.0001).

Pharmacokinetic studies also showed that scopolamine administered via an intranasal gel demonstrated rapid absorption, bringing the potential benefit of rapid onset of action.

“Scopolamine has been available for decades in a transdermal patch formulation and Defender believes its unique intranasal gel formulation, if approved, has the ability to bring fast, effective relief to any adults, including our war fighters, who are seeking to prevent the nausea and vomiting induced by motion,” said David Helton, Chief Scientific Officer of Defender.

DICLEGIS

Haymarket Media — Thu, 22 Jul 2021 11:30:14 +0000

Doxylamine succinate 10mg, pyridoxine HCl 10mg; del-rel tabs.

Diphenhydramine Injection

Haymarket Media — Thu, 22 Jul 2021 11:33:03 +0000

Diphenhydramine HCl 50mg/mL; for IV or IM inj.

DRAMAMINE

Haymarket Media — Thu, 22 Jul 2021 10:35:42 +0000

Dimenhydrinate 50mg; scored tabs.

DRAMAMINE CHEWABLE

Haymarket Media — Thu, 22 Jul 2021 10:35:44 +0000

Dimenhydrinate 50mg; scored chewable tabs; contains phenylalanine, tartrazine.

Droperidol

Haymarket Media — Thu, 22 Jul 2021 11:33:06 +0000

Droperidol 2.5mg/mL; soln for IV or IM inj.

EMEND

Haymarket Media — Wed, 15 Jun 2022 18:01:27 +0000

Aprepitant 80mg, 125mg; caps.

EMEND for ORAL SUSPENSION

Haymarket Media — Wed, 15 Jun 2022 18:00:23 +0000

Aprepitant 125mg; per pouch; pwd for oral susp after reconstitution.