News and Events
Cutis Health Announces Acquisition of Doral
April 6, 2016
Atlanta GA: Cutis Health, LLC, a specialty pharmaceutical company based in Atlanta acquires Doral (Quazepam) from Sciecure Pharma, Inc. In addition to the product New Drug Application (NDA), the acquisition includes significant inventory with extended dating. “We are pleased to re-introduce Doral to the US market as a treatment option with a broader approved insomnia indication and additional clinical advantages compared to currently available products” said Dr. Barry Patel, Co-Founder of Cutis Health.
Doral is a benzodiazepine approved for all three types of insomnia: difficulty falling asleep, difficulty staying asleep and early morning awakening. Doral was developed and introduced by Schering Plough in the 1980s and has been used by healthcare providers to successfully treat millions of people suffering from the different types of insomnia.
The U.S. insomnia market consists of approximately 50 million prescriptions annually, with over 95% filled generically. The overwhelming majority of these prescriptions are filled with zolpidem (e.g. Ambien®) and temazepam (e.g. Restoril®). Doral provides a clinical alternative to both market leaders with broader indications and less rebound insomnia. Dr. Wade Smith, Co-Founder of Cutis Health stated, “The acquisition of Doral provides a significant lead asset for our representatives while our pipeline progresses”. Cutis will be launching Doral through its unique model of distribution consisting of Independent pharmacies.
About Cutis Health
Cutis Health is a specialty pharmaceutical company focused on acquiring, developing and commercializing prescription and non-prescription products through independent pharmacies. For general information, please visit the company’s website: www.cutishealth.com.
Important Safety Information (ISI)
DORAL is contraindicated in patients with known hypersensitivity to DORAL or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of DORAL. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should be treated in an emergency department and should not be rechallenged with DORAL.
DORAL is contraindicated in patients with established or suspected sleep apnea, or with pulmonary insufficiency.
WARNINGS AND PRECAUTIONS
CNS-Depressant Effects and Daytime Impairment: Doral can produce CNS depressant effects, including daytime impairment. Patients should be cautioned against driving and other activities requiring complete mental alertness. Alcohol generally should not be used during treatment with DORAL. Additive effects occur with concomitant use of other CNS depressants. There is an increased risk of next-day psychomotor impairment if higher than the recommended dose is taken, if co-administered with other CNS depressants, or if taken with less than a full night of sleep remaining (7-8 hours). The use of Doral and concomitant CNS depressants may require downward dose adjustment and the concomitant use of Doral with other sleep-hypnotics is not recommended.
Because DORAL can cause drowsiness and a decreased level of consciousness, patients particularly the elderly, are at higher risk of falls.
Need to Evaluate for Co-morbid Diagnoses: If insomnia worsens or fails to remit after 7 to 10 days of treatment, this might be indication of an underlying illness that should be evaluated.
Abnormal Thinking and Behavior Changes: Abnormal thinking, behavior changes, and complex behaviors such as “sleep driving” (i.e., driving while not fully awake, with amnesia for the event) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events. Some of these changes include decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), bizarre behavior, and depersonalization. Visual and auditory hallucinations have also been reported. Doral should be discontinued if these symptoms occur.
Worsening of Depression: Benzodiazepines may worsen depression and consequently, appropriate precautions (e.g., increased monitoring for suicidal ideation, limiting prescription size) should be considered.
Benzodiazepine Withdrawal Syndrome: A withdrawal syndrome similar to that from alcohol (e.g., convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating) can occur following abrupt discontinuation of DORAL. Avoid abrupt discontinuation in at-risk patients of benzodiazepine withdrawal syndrome, particularly patients taking higher than recommended dose over an extended time, and the dose gradually tapered. Prescribers should monitor patients for tolerance, abuse, and dependence.
The most common adverse reactions (>1%) observed with DORAL were drowsiness, headache, fatigue, dizziness, dry mouth, and dyspepsia. Doral is classified as a Schedule IV controlled substance and patients treated with Doral should be monitored for tolerance, abuse, and dependence. For a full list of warnings and precautions, please refer to the full prescribing information.
Visit www.DoralRx.com for more details and full prescribing information.