Akorn, Inc. Launches Buprenorphine/Naloxone Sublingual Tablets And Tobramycin Injection

LAKE FOREST, Ill., Jan. 19, 2016 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq:AKRX), a leading specialty generic pharmaceutical company, today announced that it has launched Buprenorphine and Naloxone Sublingual Tablets CIII in 2mg/0.5mg and 8mg/2mg strengths. This launch follows an October 15, 2015 Food and Drug Administration (FDA) approval for the product. Additionally, Akorn recently launched Tobramycin Injection, USP 40 mg/mL in 2 mL and 30 mL multi-dose vials. This launch follows a September 2014 approval for the product.

About Buprenorphine and Naloxone Sublingual Tablets CIII

Akorn’s Buprenorphine and Naloxone Sublingual Tablets CIII in 2mg/0.5mg and 8mg/2mg strengths, marketed under the Hi-Tech Pharmacal label, are indicated for the maintenance treatment of opioid dependence. According to IMS Health, sales of Buprenorphine and Naloxone Sublingual Tablets were approximately $312 million for the twelve months ended October 31, 2015.

About Tobramycin Injection, USP

Akorn’s Tobramycin Injection, USP, 40 mg/mL in 2 mL and 30 mL multi-dose vials, marketed under the Akorn label, are indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms listed below:

• Septicemia in the pediatric patient and adult caused by P. aeruginosa, E. coli, and Klebsiella spp.
• Lower respiratory tract infections caused by P. aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E. coli, and S. aureus (penicillinase- and non-penicillinase-producing strains)
• Serious central-nervous-system infections (meningitis) caused by susceptible organisms.
• Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp, and Enterobacter spp.
• Skin, bone, and skin structure infections caused by P. aeruginosa, Proteus spp, E. coli, Klebsiella spp, Enterobacter spp, and S. aureus
• Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus spp, (indole-positive and indole-negative), E. coli, Klebsiella spp, Enterobacter spp, Serratia spp, S. aureus, Providencia spp, and Citrobacter spp.

According to IMS health, sales of all 40 mg/mL multi-dose vial presentations of Tobramycin Sulfate Injection were approximately $5 million for the twelve months ended October 31, 2015.

TOBRAMYCIN INJECTION, USP WARNINGS

Patients treated with tobramycin injection and other aminoglycosides should be under clos e clinical observation, because these drugs have an inherent potential for causing ototoxicity and nephrotoxicity.

Neurotoxicity, manifested as both auditory and vestibular ototoxicity, can occur. The auditory changes are irreversible, are usually bilateral, and may be partial or total. Eighth-nerve impairment and nephrotoxicity may develop, primarily in patients having preexisting renal damage and in those with normal renal function to whom aminoglycosides are administered for longer periods or in higher doses than those recommended. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of aminoglycoside-induced hearing loss increas es with the degree of exposure to either high peak or high trough serum concentrations. Patients who develop cochlear damage may not have symptoms during therapy to warn them of eighth-nerve toxicity, and partial or total irreversible bilateral deafness may continue to develop after the drug has been dis continued.

Rarely, nephrotoxicity may not become apparent until the first few days after cessation of therapy. Aminoglycoside-induced nephrotoxicity usually is reversible.

Renal and eighth-nerve function should be closely monitored in patients with known or suspected renal impairment and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Peak and trough serum concentrations of aminoglycosides should be monitored periodically during therapy to assure adequate levels and to avoid potentially toxic levels. Prolonged serum concentrations above 12 mcg/mL should be avoided. Rising trough levels (above 2 mcg/mL) may indicate tissue accumulation. Such accumulation, excessive peak concentrations, advanced age, and cumulative dos e may contribute to ototoxicity and nephrotoxicity (see PRECAUTIONS). Urine should be examined for decreased specific gravity and increased excretion of protein, cells, and casts. Blood urea nitrogen, serum creatinine, and creatinine clearance should be measured periodically. When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of impairment of renal, vestibular, or auditory function requires dis continuation of the drug or dosage adjustment.

Tobramycin injection should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug.

Concurrent and sequential us e of other neurotoxic and/or nephrotoxic antibiotics, particularly other aminoglycosides (e.g., amikacin, streptomycin, neomycin, kanamycin, gentamicin, and paromomycin), cephaloridine, viomycin, polymyxin B, colistin, cisplatin, and vancomycin, should be avoided. Other factors that may increase patient risk are advanced age and dehydration.

Aminoglycosides should not be given concurrently with potent diuretics, such as ethacrynic acid and furosemide. Some diuretics themselves cause ototoxicity, and intravenously administered diuretics enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Aminoglycosides can caus e fetal harm when administered to a pregnant woman (see PRECAUTIONS).

About Akorn

Akorn, Inc. is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India where the Company manufactures ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Additional information is available on the Company's website at www.akorn.com.

Forward Looking Statements

This press release includes statements that may constitute "forward looking statements", including projections of sales and other statements regarding Akorn's launches, regulatory approvals, goals and strategy. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Factors that could cause or contribute to such differences include, but are not limited to: the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations; changes in the laws and regulations and such other risks and uncertainties outlined in Akorn's periodic public filings with the Securities and Exchange Commission and in other written or oral investor communications. Other factors besides those listed there could also adversely affect our results. Except as expressly required by law, Akorn disclaims any intent or obligation to update these forward-looking statements.

The addressable IMS market size figures presented in this press release outline the approximate aggregate size of the potential market and are not forecasts of our future sales.

Investors/Media: Dewey Steadman Executive Director, Investor Relations (847) 582-6923 investor.relations@akorn.com