Product Overview

US WorldMeds is a specialty pharmaceutical company located in Louisville, Kentucky. Our mission is to develop, license and commercialize unique and significant pharmaceuticals that address unmet medical needs or overcome the limitations of existing products.

Our product line includes AP-rated Revonto^® (dantrolene sodium for injection) for the treatment of malignant hyperthermia, MYOBLOC^® (rimabotulinumtoxinB) Injection for the treatment of cervical dystonia in adults and APOKYN^® (apomorphine hydrochloride injection) for the acute, intermittent treatment of hypomobility, "off" episodes associated with advanced Parkinson's disease. In addition, another non-narcotic drug product (Lofexidine) for the treatment of opiate withdrawal symptoms is well under development.

APOKYN is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease (PD). When injected during an off episode, APOKYN may enable people with PD to walk, talk, and move around more easily. APOKYN works quickly-within 20 minutes. APOKYN is used to reverse off-episode motor symptoms when they occur. APOKYN should be used in addition to oral PD medicines and does not replace them.
MYOBLOC is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. In numerous published studies, treatment with MYOBLOC resulted in a clinically and statistically significant improvement in head position and neck pain for patients with cervical dystonia.^1-4 This was demonstrated in botulinum toxin naïve patients as well as patients previously treated with a botulinumtoxin.^1-4 MYOBLOC was the first FDA-approved treatment for cervical dystonia, and remains the only type B botulinum toxin approved for use in the US.^5,6
Revonto (dantrolene sodium for injection) is indicated, along with appropriate supportive measures, for the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Revonto dramatically reduces reconstitution time of dantrolene sodium for injection to 20 seconds or until the solution is clear. It retains the cost savings of US WorldMeds’ original generic product while offering a significant improvement in patient pharmacotherapy.

References

1. Brashear A, Lew MF, Dykstra DD, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology. 1999;53(7):1439-1446. 2. Brin MF, Lew MF, Adler CH, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999;53(7):1431-1438. 3. Pappert EJ, Germanson T; Myobloc/Neurobloc European Cervical Dystonia Study Group. Botulinum toxin type B vs. type A in toxin-naïve patients with cervical dystonia: randomized, double-blind, noninferiority trial. Mov Disord. 2008;23(4):510-517. 4. Data on file (MYO-026-1207). Malvern, PA: Solstice Neurosciences, Inc; 2007. 5. FDA approval letter. Myobloc for cervical dystonia. December 8, 2000. 6. FDA approval letter. Botox for cervical dystonia. December 21, 2000.

Important Safety Information for Revonto

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Revonto is indicated, along with appropriate supportive measures, for the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. It is also indicated preoperatively and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible. Malignant hyperthermia is life threatening and requires immediate medical attention and treatment. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy. There have been reports of thrombophlebitis following administration of intravenous dantrolene. There have been rare reports of urticaria and erythema possibly associated with the administration of i.v. dantrolene sodium.

CONTRAINDICATIONS: None.

For additional information on Revonto, please visit www.revonto.com.

To download the Revonto package insert click here.

For More information on Malignant Hyperthermia please visit The Malignant Hyperthermia Association of the United States (MHAUS).

Important Safety Information for MYOBLOC

Distant Spread of Toxin Effect

Postmarketing reports indicate that the effects of MYOBLOC and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses. (See WARNINGS, PRECAUTIONS, and OVERDOSE sections of Full Prescribing Information).

MYOBLOC (rimabotulinumtoxinB) Injection is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. Units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products.

Before administering MYOBLOC, physicians should consult the full Prescribing Information and Medication Guide.

The most frequently reported adverse events with MYOBLOC are dry mouth, dysphagia, dyspepsia, and injection site pain. The vast majority of these adverse events were mild to moderate, temporary, self-resolving, and more common with higher doses. These adverse events may occur within the first week following treatment and may have a duration of several months. In controlled clinical trials, few patients (<1%) stopped treatment due to dry mouth or dysphagia. There is a reduced frequency of dry mouth and dysphagia reported with continued treatment. Dysphagia has commonly been reported by patients treated with all botulinum toxins for cervical dystonia.

Caution should be exercised when administering MYOBLOC to individuals with motor neuron disease (e.g., amyotrophic lateral sclerosis), peripheral motor neuropathic diseases (e.g., motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome). These patients may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC. In these patients, rare cases of dysphagia severe enough to cause aspiration pneumonia or to warrant the insertion of a gastric feeding tube have also been reported.

Coadministration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.

For More information on MYOBLOC, please visit www.myobloc.com.

Important Safety Information for APOKYN

APOKYN is indicated for the acute, intermittent treatment of hypnomobility, off episodes (end-of-dose wearing-off and unpredictable on-off episodes) associated with advanced Parkinson's disease. APOKYN has been studied as an adjunct to other medications.

Contraindications: APOKYN is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients (notably metabisulfate). Concomitant use of APOKYN with 5HT3 antagonists is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

Nausea and Vomiting: At recommended doses of apomorphine, severe nausea and vomiting can be expected. Therefore, trimethobenzamide hydrochloride should be started 3 days prior to the initial dose of APOKYN and continued for at least 2 months. In clinical trials, 50% of patients (262/522) discontinued trimethobenzamide hydrochloride after 2 months of APOKYN.

Symptomatic Hypotension: Dopamine agonists, including APOKYN, can cause hypotension, orthostatic hypotension, and syncope. Alcohol, antihypertensive medications, and vasodilating medications may potentiate the hypotensive effect of apomorphine. These adverse events occurred with initial dosing and long-term treatment. Whether hypotension contributes to other significant events seen (eg, falls) is unknown.

SC Injection: APOKYN should be administered by subcutaneous injection, NOT intravenously, because serious adverse events may occur. Patients and caregivers must receive detailed instructions in the preparation and injection of doses, with particular attention paid to the correct use of the dosing pen.

Cardiac Events: QT Prolongation-Caution is recommended when administering APOKYN to patients with increased risk of QT prolongation, such as those with hypokalemia, hypomagnesemia, bradycardia, or a genetic predisposition, or who use other drugs that prolong the QT/QTc interval. Coronary Events-APOKYN reduces resting systolic and diastolic blood pressure and has the potential to exacerbate coronary (and cerebral) ischemia. Therefore, exercise caution when prescribing APOKYN for patients with known cardiovascular and cerebrovascular disease.

Intense Urges: Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including APOKYN.

Potential for Abuse: There are reports of apomorphine abuse by patients with Parkinson's disease in other countries. These cases are characterized by increasingly frequent dosing leading to hallucinations, dyskinesia, and abnormal behavior.

Falls: Patients with Parkinson's disease (PD) are at risk of falling due to the underlying postural instability and concomitant autonomic instability seen in some patients with PD, and from syncope caused by the blood pressure lowering effects of the drugs used to treat PD. Subcutaneous apomorphine might increase the risk of falling by simultaneously lowering blood pressure and altering mobility.

Hallucinations / Psychotic-Like Behavior: Hallucinations were reported in some patients during clinical development. Post marketing reports indicate that patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior after starting or increasing the dose of APOKYN. Other drugs prescribed to improve the symptoms of Parkinson's disease can have similar effects on thinking and behavior. This abnormal thinking and behavior can consist of one or more of a variety of manifestations, including paranoid ideation, delusions, hallucinations, confusion, disorientation, aggressive behavior, agitation, and delirium.

Patients with a major psychotic disorder should ordinarily not be treated with APOKYN because of the risk of exacerbating psychosis. In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of APOKYN.

Falling Asleep During Activities of Daily Living (ADL): There have been literature reports of patients treated with apomorphine subcutaneous injections who suddenly fell asleep while engaged in ADL. Patients should be advised not to drive or participate in potentially dangerous activities until it is known how APOKYN affects them. Patients should be continually reassessed for daytime drowsiness or sleepiness.

Adverse Events: Injection-site reactions, including bruising, granuloma, and pruritus, have been reported. The most common adverse events seen in controlled trials were yawning, dyskinesias, nausea and/or vomiting, somnolence, dizziness, rhinorrhea, hallucinations, edema, chest pain, and increased sweating, flushing, and pallor.

Melanoma: Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear. For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using APOKYN for any indication. Periodic skin examinations should be performed by appropriately qualified individuals (eg, dermatologists).

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-877-727-6596 (877- 7APOKYN). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

All trademarks are the property of their respective owners.

For more information on APOKYN, please visit www.apokyn.com

APOKYN and Revonto are registered trademarks of US WorldMeds, LLC.
MYOBLOC is a registered trademark of Solstice Neurosciences, LLC, a wholly-owned subsidiary of US WorldMeds, LLC.

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