Impax to Present Data on Rytary® (Carbidopa and Levodopa) Extended-Release Capsules, Zomig® (Zolmitriptan) Nasal Spray and Investigational Drug IPX203 at the 2017 American Academy of Neurology®...

HAYWARD, Calif., April 21, 2017 /PRNewswire/ --Impax Laboratories, Inc.(NASDAQ: IPXL) today announced that it will be presenting data from the Company's neurology clinical development programs, including data from a single-dose Phase 2a study on investigational drug IPX203 in patients with advanced Parkinson's Disease in the Emerging Science Program at the American Academy of Neurology conference in Boston, MA from April 22 – April 28, 2017.

"This is an important meeting for our Specialty Pharma Division that markets Rytary and Zomig Nasal Spray.  It underscores our commitment to advancing the science for treating neurological disorders," said Paul Bisaro, Impax President and Chief Executive Officer.  "We see patients cope with extraordinary difficulties while living with Parkinson's Disease and migraines which inspires us to continue to seek to develop safe and effective treatment options."

Key presentations include:

Rytary (Carbidopa and Levodopa) Extended-Release Capsules
Topic: Movement Disorders, Session Name:  Parkinson's Disease:  Therapeutics and Telehealth I
Sunday, April 23

• Title: "Duration of "on" Periods after Treatment with Extended-Release vs. Immediate-Release Carbidopa-Levodopa in Patients with Advanced Parkinson's Disease" (Poster presentation, PN-020, Authors: William G. Ondo, M.D.; Margery M. Mark, M.D.; Nishit B. Modi, Ph.D.; Sarita Khanna, Ph.D.; Suneel Gupta, Ph.D.)
• Title: "Dosing and efficacy of extended-release carbidopa-levodopa in advanced Parkinson's Disease patients with or without concomitant medication use" (Poster presentation, PN-027, Authors: Suneel Gupta, Ph.D.; Sarita Khanna, Ph.D.; Sherron Kell, M.D.; Robert Rubens, M.D., MBA)
• "Effect of "Off" Time on The Recommended Starting Dose for Rytary" (Poster presentation, PN-030, Authors: Nishit B. Modi, Ph.D.; Sarita Khanna, Ph.D.; Suneel Gupta, Ph.D.)

Wednesday, April 26, 2017

• Title "Improvements in Activities of Daily Living and Quality of Life Measures in Hoehn & Yahr Subgroups of Advanced Parkinson's Disease Patients Following Treatment with IPX066, Extended-Release Carbidopa-Levodopa" (Poster presentation, PN-008, Authors: Rohit Dhall, M.D.; Ramon Gil, M.D.; Elizabeth Lindemulder, M.S.; Robert Rubens, M.D., MBA; Suneel Gupta, Ph.D.)

Investigational Drug IPX203
Session Name:  Emerging Science
Tuesday, April 25, 2017

• Title: "Motor Effects and Safety of IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa, in Advanced Parkinson's Disease: A Single Dose Study" (Poster presentation, PN-3964, Authors: Mark Stacy, M.D.; Victor Biton, M.D.; Jason Aldred, M.D.; Aaron Ellenbogen, M.D.; Robert Rubens, M.D., MBA; Nishit B. Modi, Ph.D.; Aravind Mittur, Ph.D.; Sarita Khanna, PhD; Suneel Gupta, Ph.D.)

Zomig (Zolmitriptan) Nasal Spray
Topic:  Headache, Session Name:  Headache:  Clinical Trials and Disease Burden
Friday, April 28, 2017

• Title: "Efficacy of Zolmitriptan Nasal Spray for the Treatment of Acute Migraine in Adolescents: Subgroup Analysis by Age" (Platform presentation, PN-005, Authors: Paul Winner, M.D.; Robert Rubens, M.D., MBA; Nathan Rustay, Ph.D.; Sarita Khanna, Ph.D.; Heather Wray, M.D.)

About RYTARY (carbidopa and levodopa) extended-release capsules
Rytary was first approved by the U.S. Food and Drug Administration (FDA) in January 2015 for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.

Indication
RYTARY (carbidopa and levodopa) extended-release capsules are indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Important Safety Information
CONTRAINDICATIONS
RYTARY is contraindicated in patients who are currently taking or have recently (within 2 weeks) taken a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine). Hypertension can occur if these drugs are used concurrently.

WARNINGS AND PRECAUTIONS
Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with levodopa (a component of RYTARY) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events have been reported more than 1 year after initiation of treatment.  Before initiating treatment with RYTARY, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with RYTARY, such as concomitant sedating medications or the presence of a sleep disorder. Prescribers should consider discontinuing RYTARY in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating). If a decision is made to continue RYTARY, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent.
Withdrawal-Emergent Hyperpyrexia and Confusion: A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction of, withdrawal of, or changes in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction in patients taking RYTARY. If the decision is made to discontinue RYTARY, the dose should be tapered to reduce the risk of hyperpyrexia and confusion.
Cardiovascular Ischemic Events: Cardiovascular ischemic events have occurred in patients taking RYTARY. In patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias, cardiac function should be monitored in an intensive cardiac care facility during the period of initial dosage adjustment.
Hallucinations/Psychosis: There is an increased risk for hallucinations and psychosis in patients taking RYTARY. Hallucinations present shortly after the initiation of therapy and may be responsive to dose reduction in levodopa. Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming. Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium. 
Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with RYTARY. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of RYTARY.
Impulse Control/Compulsive Behaviors: Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including RYTARY, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with RYTARY. Consider a dose reduction or stopping the medication if a patient develops such urges while taking RYTARY.
Dyskinesia: RYTARY can cause dyskinesias that may require a dosage reduction of RYTARY or other medications used for the treatment of Parkinson's disease. 
Peptic Ulcer Disease: Treatment with RYTARY may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.
Glaucoma: RYTARY may cause increased intraocular pressure in patients with glaucoma.  Monitor intraocular pressure in patients with glaucoma after starting RYTARY.
Melanoma: Patients with Parkinson's disease have a higher risk of developing melanoma than the general population. Patients and providers are advised to monitor for melanoma frequently and on a regular basis when using RYTARY.  

ADVERSE REACTIONS:
Clinical Trials Experience:    

• Early Parkinson's Disease: Most common adverse reactions (incidence ≥ 5 % and greater than placebo) are nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.
• Advanced Parkinson's Disease: Most common adverse reactions (incidence ≥ 5 % and greater than oral immediate-release carbidopa-levodopa) are nausea and headache.

Postmarketing Experience: Reported adverse reactions identified during post approval use of RYTARY include suicide attempt and ideation. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to RYTARY exposure.

DRUG INTERACTIONS: 
Monitor patients taking selective MAO-B inhibitors and RYTARY.  The combination may be associated with orthostatic hypotension.  Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide), isoniazid, and iron salts or multivitamins containing iron salts may reduce the effectiveness of RYTARY.  Monitor patients for worsening Parkinson's symptoms.

USE IN SPECIFIC POPULATIONS:
Pregnancy and nursing mothers: RYTARY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  Caution should be exercised when RYTARY is administered to a nursing woman.
Pediatrics: Safety and efficacy in pediatric populations have not been established.

OVERDOSAGE:
The acute symptoms of levodopa/dopa decarboxylase inhibitor overdosage can be expected to arise from dopaminergic overstimulation. Doses of a few grams may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g., hypotension, tachycardia) and more severe psychiatric problems at higher doses. 

GENERAL DOSING AND ADMINISTRATION INFORMATION: 
See Full Prescribing Information for instructions for starting levodopa-naïve patients on RYTARY and converting patients from immediate-release carbidopa and levodopa to RYTARY (Table 1). The dosages of other carbidopa and levodopa products are not interchangeable on a 1:1 basis with the dosages of RYTARY.

RYTARY should not be chewed, divided, or crushed.  Swallow RYTARY whole with or without food.  A high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours.
For patients who have difficulty swallowing capsules, administer RYTARY by carefully twisting apart both halves of the capsule.  Sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons) and consume the mixture immediately.  Do not store the drug/food mixture for future use.

For full Prescribing Information, please go to:  http://documents.impaxlabs.com/rytary/pi.pdf. 

About ZOMIG (zolmitriptan) Nasal Spray
ZOMIG Nasal Spray was first approved by the U.S. Food and Drug Administration (FDA) in September 2003 for the acute treatment of migraine attacks, with or without aura, in adults. In clinical trials, ZOMIG Nasal Spray provided relief in as soon as 15 minutes for some patients and the maximum effect was reached within 2–4 hours for most adult patients. At 2 hours, 69% of patients taking the 5mg dose had headache response (taking the patient from moderate to severe pain to mild or no pain) and 36% were pain free.

Indication
ZOMIG Nasal Spray is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older.

Limitations of Use:
Use ZOMIG only after clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache. ZOMIG Nasal Spray is not recommended in patients with moderate to severe hepatic impairment.

Important Safety Information

• ZOMIG is contraindicated in patients with
• History of coronary artery disease (CAD) or coronary artery vasospasm
• Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
• History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
• Peripheral vascular disease
• Ischemic bowel disease
• Uncontrolled hypertension
• Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan), or an ergotamine-containing medication
• Monoamine oxidase (MAO)-A inhibitor used in past 2 weeks
• Known hypersensitivity to ZOMIG, ZOMIG-ZMT, or ZOMIG Nasal Spray.  Anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema have occurred in patients receiving zolmitriptan.
• Myocardial ischemia, myocardial infarction and Prinzmetal Angina: Perform cardiac evaluation in patients with multiple risk factors and, if satisfactory, administer first dose of ZOMIG in a medically supervised setting
• Arrhythmias: Discontinue ZOMIG if these occur
• Sensations of tightness, pain and pressure in the chest, throat, neck, and jaw commonly occur after treatment with 5-HT1 agonists like ZOMIG and are usually non-cardiac in origin: Perform a cardiac evaluation if these patients are at cardiac risk
• Cerebrovascular events, some fatal; non-coronary Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions; and increases in blood pressure (which have been very rarely associated with serious clinical events) have been reported with ZOMIG. Discontinue use of ZOMIG if any of these events occur
• Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
• Serotonin syndrome may occur with triptans, including ZOMIG, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Discontinue ZOMIG if serotonin syndrome is suspected
• The most common adverse reactions in adults (≥5% and > placebo; in any dosage strength) in clinical trials for ZOMIG Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness
• The most common adverse reaction in pediatrics (ages 12 and 17 years; ≥5% and > placebo; in either the 2.5 or 5 mg ZOMIG dose groups) in clinical trials for ZOMIG Nasal Spray was unusual taste
• For full Prescribing Information, please go to https://www.azpicentral.com/zomig-nasal-spray/zomignasalspray.pdf

About IPX203
IPX203 is an investigational extended-release oral capsule formulation of carbidopa and levodopa, being studied as a potential treatment for symptoms of Parkinson's Disease.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.

About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams, and ointments. For more information, please visit the Company's Web site at: www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in revenues and operating income; the Company's ability to successfully develop and commercialize pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the substantial portion of the Company's total revenues derived from sales of a limited number of products; the impact of consolidation of the Company's customer base; the impact of competition; the Company's ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection with the operation of the Company's manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company's operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company's agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company's products; the Company's determinations to discontinue the manufacture and distribution of certain products; the Company's ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements; the Company's ability to successfully conduct clinical trials; the Company's reliance on third parties to conduct clinical trials and testing; the Company's lack of a license partner for commercialization of NUMIENT^TM (IPX066) outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company's supply chain; the Company's policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company's products; the effect of current economic conditions on the Company's  industry, business, results of operations and financial condition; disruptions or failures in the Company's information technology systems and network infrastructure caused by third party breaches or other events; the Company's reliance on alliance and collaboration agreements; the Company's reliance on licenses to proprietary technologies; the Company's dependence on certain employees; the Company's ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company's government contracts; the Company's ability to protect its intellectual property; exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company's ability to manage growth, including through potential acquisitions and investments;  the risks related to the Company's acquisitions of or investments in technologies, products or businesses; the restrictions imposed by the Company's credit facility and indenture; the Company's level of indebtedness and liabilities and the potential impact  on cash flow available for operations; uncertainties involved in the preparation of the Company's financial statements; the Company's ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company's business; the location of the Company's manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

Contact:                                                                   
Mark Donohue
Investor Relations and Corporate Communications      
(215) 558-4526                                                            
www.impaxlabs.com

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SOURCE Impax Laboratories, Inc.