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 NUMIENTTM (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.