loading...
Transforming the Pharmaceutical Industry
through Innovation

News and Events

News:

Pharmaceutical Franchising Introduced by Galt Phranchise Systems and Holds First Training Class

April 4, 2018

ATLANTA, GA Galt Phranchise Systems, LLC (GPS) announces the launch of the pharmaceutical industry’s first franchising model. GPS is the first and only pharmaceutical company which operates a sales platform based upon the spirit of entrepreneurialism through Phranchising (Pharmaceutical Franchising). Over 500 sales territories have been created across the United States and each Phranchise owner has exclusive rights to represent Galt Pharmaceuticals®, LLC (Galt) products after they are certified to promote in their local communities according to FDA guidelines and approved labeling. A milestone for GPS was reached in April with the first class of 35 Phranchisees and Authorized Sales Representatives successfully completing training.

“The Galt Phranchise model is a unique and efficient system that emphasizes local customer service addressing individual physician and patient therapeutic needs” said Galt Co-Founder, Barry Patel, Pharm.D. Galt Phranchisees leverage their existing and newly established relationships within the medical/pharmacy community to address unmet clinical needs that may be addressed with FDA approved pharmaceuticals. Although, the operations and management of territories is best left to the Phranchisee in this groundbreaking model, the support for medical affairs, safety reporting, product marketing, distribution and overall FDA compliance is provided through Galt corporate resources. “As the pharmaceutical industry continues to evolve, one thing remains constant in that prescribers of medication still seek education and dialogue on features and benefits of pharmaceuticals and Galt is personalizing this process through entrepreneurs who intimately know their communities” said Galt Co-Founder Wade Smith.

This class of phranchisees are establishing their businesses through the promotion of Galt's current lead product, Doral (Quazepam). Doral has FDA indications for the treatment of insomnia characterized by patients having difficulty falling asleep, difficulty maintaining sleep and early morning awakenings. “Doral offers HCPs a unique alternative to the many available sleep-aids on the market and Galt Phranchisees have been trained on FDA approved prescribing information ensuring they present Doral in an ethical and compliant manner to healthcare providers in their community” said Wolfgang Freund, Vice President of Sales.

Galt seeks qualified entrepreneurs that would like to own a piece of their own local pharmaceutical company business and can email phranchise@galtrx.com to request information.

About Galt Pharmaceuticals

A unique Pharmaceutical Company, Galt has found a better way to enhance the quality of life of patients with products that meet unmet clinical needs, while creating life-changing opportunities for entrepreneurs, our employees and the individuals within the communities we serve. Galt’s founders believe there’s a better way than big pharma where local owners build their own pharmaceutical business in their own market. Galt is the first and only pharmaceutical company to create a unique franchise (phranchise) concept. which moves product representation and engagements from a corporate headquarters to a local territory. Phranchisees provide education to local healthcare providers about high value medications and share a percentage of sales with Galt who owns the pharmaceutical assets and manages functions such as drug research, regulatory approval, compliance and supply chain. Galt currently owns FDA approved assets in the insomnia and pain markets, with products offering clinical advantages compared to currently promoted products in their respective therapeutic classes. Learn more at www.galtrx.com.

Important Safety Information (ISI)

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.1), Drug Interactions (7)]. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

CONTRAINDICATIONS

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.

 

ADVERSE REACTIONS

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.

Share the resource:

Share on Facebook Share on Twitter Share on LinkedIn